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December 22nd, 2010
05:08 PM ET

Glucose test strips recalled

Abbott Diabetes Care is voluntarily recalling 359 million glucose test strips because they may be defective and cause false low blood glucose readings, the Food and Drug Administration (FDA) announced Wednesday.

The strips don't absorb enough blood for proper monitoring, the agency says. The strips are sold in the United States and in Puerto Rico.

The strips are marketed under the brand names Precision Xceed Pro; Precision Xtra; MediSense Optium; Optium; OptiumEZ and ReliOn Ultima, and are used with Abbott blood glucose monitoring systems bearing the same name. The monitoring systems are not being recalled.

The false readings can cause patients to try to raise their blood sugar needlessly, or not treat elevated levels because of low reading that are false.

"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA's Center for Devices and Radiological Health. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."

The strips in question were manufactured between January and May of this year and sold in stores and online.  They were used in hospitals and other health care facilities.  Abbott says the problem may be the age of the strips and how they were stored–in particular,  exposure to high temperatures for extended periods of time may be a contributing factor.  The company voluntarily started the recall after a "routine internal quality review" found the problem.  So far they've reported 22 safety reports to the FDA.

"Abbott is committed to the highest quality standards and is taking action to address and prevent this issue from recurring," Greg Miley, an Abbott Diabetes Care spokesman, said. In the meantime, Abbott will replace the affected strips at no charge.  The lot numbers, along with recall information for both consumers and health care providers can be found at www.precisionoptiuminfo.com.


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soundoff (39 Responses)
  1. DiosGX

    This disgusts me on the sole grounds of why the strips wouldn't work. Ever heard of a "margin"?

    December 22, 2010 at 18:14 | Report abuse | Reply
    • Blkbart

      I take it you are not diabetic!

      December 22, 2010 at 21:17 | Report abuse |
    • Bek

      Perhaps you are unaware that many people with diabetes adjust their insulin, food, and activity based on readings from blood glucose meters. For these strips to be recalled they must have had dangerous excursions from any acceptable margin.

      December 23, 2010 at 00:51 | Report abuse |
    • Christine

      For you to say that – either you are stupid or not a diabetic.

      You adjust your insulin based on readings – that would be short or long acting insulin.

      So say you ate something and it shot up to 354, you would need to adjust the insulin accordingly. Get it?

      December 23, 2010 at 08:28 | Report abuse |
  2. maybrc

    DiosGX, you wrote "This disgusts me on the sole grounds of why the strips wouldn't work. Ever heard of a 'margin'?" Are you
    a total idiot? Do you realize people depend on strips such as the ones recalled for their lives? And no, that is not an exaggeration!! Why must you comment if you are just going to be an ignorant a$$?

    December 23, 2010 at 00:16 | Report abuse | Reply
  3. Anne S.

    I do not use any of the strips mentioned, I use a different brand, This margin thing your talking about is new to me as a diabetic. Now if your referring to the sliding scale that might sound more right. With the sliding scale you adjust your insulin. Actually I take 2 insulins, one is a long acting one and taken every 12 hours, and my other one is a short acting one in which the sliding scale is used and that is used at meal times. My short acting insulin starts out with 2 base units, and when my meter shows 151 then I take 4 units, and when it hits 201 I take 5 units. You add an extra unit on at every 50 mark. On my sliding scale after 301 I take 7 units and that's all.l If you want to call it margin that's you, but to me it's the sliding scale.

    December 23, 2010 at 05:14 | Report abuse | Reply
    • brat

      Anne, that is thorough information. However why bother explaining that to DiosGX. It is obvious that he/she knows everything!

      December 23, 2010 at 08:04 | Report abuse |
  4. Whitney

    DiosGX, are you kidding me?! A margin is unacceptable as a diabetic, if your blood sugar is too low and you don't know it, because these strips tell you it's fine, you can go into a diabetic coma and die...You really should be more educated on this matter before you make such an idiotic comment.

    Fortunately, my dad doesn't use any of these strips.

    December 23, 2010 at 07:15 | Report abuse | Reply
  5. Gene

    This report is serious indeed. There is no room for error in blood glucose testing.

    As a Type 1 diabetic for 34 years, I have relied on the accuracy of blood glucose testing. Maintaining good control life depends on knowing one's blood sugar. I can say that I will live a longer life because of accurate blood glucose testing methods. And I have no complications at this point. Knock on wood.

    December 23, 2010 at 08:06 | Report abuse | Reply
  6. bill

    I think everyone should have to sugar test. Randomly. How else will we judge their moral fiber?

    December 23, 2010 at 08:13 | Report abuse | Reply
  7. Ketoacidosis

    Bah, eat more take less insulin. Life is better that way. forget about the dry skin, funny thyroid bumps (you know what the thyroid is right? a mass that sits near the throat area..produces a bunch of helpful hormones to keep your body working), the 'I have to pee' every 15 minutes, The copious amounts of liquid consumed(ever downed a liter of water every 30 minutes? I have .. let me tell you its thirst quenching), the temporary loss of vision.. who cares its temporary it will be restored no?, the wounds that never heal (I got a scratch on my foot.. its been oozing blood for months now. and its all dry and crusted around the edges.. its getting deeper i think? polysporin doesnt heal it what a waste of cash.. so instead of replacing the tube when i ran out I got an extra large pizza with extra cheese ❤ ) ahhh. let me tell you what type I diabetics of the world.. its a saweeeeet life not caring about anything!

    December 23, 2010 at 08:51 | Report abuse | Reply
    • Anne S.

      Ketoacidosis
      If you are a diabetic you sure aren't doing yourself any justice. If you would have your blood sugar under control you wouldn't have to go visit the bathroom every 30 minutes. You obviously don't care about yourself. If you do have a sore on your foot, then you should get to a foot doctor. Polysprin cream isn't the answer. If you woulld watch your diet a lot of your symptoms would disappear. You can help yourself if you put your mind to it. Surely you must have a death wish on yourself.

      December 23, 2010 at 09:45 | Report abuse |
  8. razzlea

    http://razzlea.blogspot.com/

    December 23, 2010 at 08:53 | Report abuse | Reply
  9. angela

    My husband is a diabetic so far so good. His doctor said if your sugar goes down to forty or above 400 u have to call 911. Thank God so far this did not happen. He has 2 testing meters. One day I asked him to check mine and it said 22. Omg I was gonna call 911 but when he used the other meter it was normal this is disgusting that u can't be sure if the meter is correct.

    December 23, 2010 at 09:16 | Report abuse | Reply
    • Mike Hill in St. Louis

      Angela: Your husband's Doctor is a dangerous Quack. The sugar range is 80 to 150. If his sugar goes down to 40, he would either be in a Diabetic Coma or dead. If my sugar goes below 80, I start visibly shaking and sweating, and need to drink something sweet. Glucose tablets do not work for me. You really need to get him a new Doctor who know what he is doing.

      December 23, 2010 at 09:40 | Report abuse |
    • soren

      Not true. my blood sugar has been 9, and I was fully capable of correcting it on my own (though a little messed up). Dont waste money on an ambulance

      December 23, 2010 at 09:49 | Report abuse |
    • Anne S.

      There is a way to check the meter for accuracy. Haven't you heard of the testing solution that comes with your new meter? Surely you got a bottle of it. On the bottle of testing solution it shows the range of what it is suppose to be. I've had several ty[es of meters and with each one a bottle of the testing solution came with it. Maybe you should read the directions when you get a new meter.

      December 23, 2010 at 09:54 | Report abuse |
    • Fawn

      Some meters have a range where they routinely run higher or lower than lab readings. Did you recently do any cleaning or use any chemicals? That can throw off the readings (I've experienced that). As a type 1 diabetic I have had lows where I was barely functional at 15, and unconscious at 12 in my 18+ yrs as a diabetic (but those were only in the last 8 yrs). I think there's a range of functionality and variability with the disease, a common phrase that comes to my mind is YMMV (your mileage may vary). Basing your frustration off of one test doesn't do much for you.

      December 23, 2010 at 10:04 | Report abuse |
  10. Mike Hill in St. Louis

    I take 10 units of Novolog before meals, 35 units of Lantus before bed plus 40mg of Actos every morning. Although I do not use those brands, I NEED acurate strips. There is no MARGIN of error.

    December 23, 2010 at 09:35 | Report abuse | Reply
  11. megs ma

    Hey Anne. FYI blood sugar is often difficult to control
    Even with GREAT docs and all the latest pumps and monitors. My daughter has been conscious but confused with a reading as low as 34. Her blood sugar also soars over 400 for no reason. Even adrenelin during a high-school soccer game can cause a "false" spike in blood sugar which if corrected according to her ratios would cause a deadly low. Unfortunately this disease is so much more difficult and deadly than many people realize. Obviously the medical community needs to provide more info for the public-it would reduce the number of ignorant "know it alls" substantially

    December 23, 2010 at 10:07 | Report abuse | Reply
  12. Tiffany

    I have been a type 1 diabetic for 15 years...it's not easy, but it is treatable and controllable. I am greatful that i have a disease that i can manage, rather than one i can't. At the age of 7 i was diagnosed. When i was 12 (it had been 5 years since i had any brush-ups on the seriousness of the disease) i had missed a few injections and fell very ill. When i had went to the doctors office, he misdiagnosed me with the flu an sent me home. It turned out that i had dka and had it for about 48 hours. I became unconcious and was rushed to the hospital. My meter was giving me readings like 110-120 mg/dl...so we had no idea that dka had other symptoms simular to the flu. I was in critical condition and the doctors in the er had to revive me. I was on life support and in a coma for 6 days. I was in the hospital for close to 2 months. It was a miracle that i had survived, since the doctors had told my mother that they didn't think i was going to make it. I think EVERYONE needs to brush-up on knowledge of this disease at least every year, and had their
    Meters calibrated at every visit (mine at that time during dka, was a flaw in the meter). Diabetes does suck, but at least it can be managed.

    December 23, 2010 at 10:17 | Report abuse | Reply
  13. king9952

    To angela,i dont mean to diss ur diabetic/insulin knwoledge, the physician who instructed ur husband to report BS down to 40 seems to had attended his medical school in TALLIBAN. The last time i check, if blood sugar of any human goes bellow 60, emmergncy call must be placed, If at 60, half cup of fruit juice or orange juice must be given, if at 500 or above, emergency call must be placed.

    December 23, 2010 at 10:21 | Report abuse | Reply
    • Shannon

      King, I don't mean to diss *your* diabetic/insulin knowledge, but if I placed an emergency call every time my blood sugar went below 60, I'd have paramedics at my house several times per week. In addition, I've been over 500 many times, and other than increasing insulin, checking for ketones, etc., there's not much to do.

      Clearly, most people are thinking about Type 2 diabetes when respondig here. But Type 1s (like me) have to test our blood sugar 10+ times per day, and based on those results, we take insulin, eat, exercise, etc. On an average day, my blood sugar can go from the low 30s to the high 200s – even with the best medical technology available. In fact, I've have been so low that my meter display read "LO" instead of giving an actual number.

      While Type 2s might be told that a blood sugar below 60 is an emergency, Type 1s know that it's not really an emergency until you are unable to drink or eat. Type 1s carry emergency Glucagon kits to treat severe low blood sugar.

      A recall like this has HUGE ramifications in Type 1 diabetics. Our lives are in danger every single minute of every day. If our glucose testing is inaccurate, our risk increases. That's why a recall like this is so important.

      December 23, 2010 at 11:18 | Report abuse |
  14. melissa

    This is not cool at all. I am supposed to be taking a glucose test in 2 weeks. I'm gonna make sure that none of those strips are used for me. This is a pretty scary situation.

    December 23, 2010 at 10:38 | Report abuse | Reply
    • Shannon

      Melissa, if you're having a glucose tolerance test done (often given to pregnant women and people at risk for diabetes), the technology used is NOT test strips. Instead, you will have several blood draws (from your arm), and the lab will test on highly sophisticated equipment.

      The recalled test strips are for home glucose testing.

      December 23, 2010 at 11:20 | Report abuse |
  15. Podiebell

    Every glucose strip has what is called a "margin". Even the best strips are only 80% accurate. The FDA allows them to be this way. So, for example, your blood sugar is 150 but your machine reads it at 120. That is only 80% correct but the strips and the machine are not flawed. If your always testing low then your a1c would show the real story. These strips in the story must have been out of the range that is considered safe. I have used the cheapy Walmart Relion strips before and I found them to be extremely unreliable. I switched back to my OneTouch Ultra. It's always best to check your sugar levels twice if you find the level to be outside normal and to focus on how you feel as well. By the way, even at 150, your blood sugar is considered ok. Sugar doesn't start affecting your kidneys until it's over 150. That's when the kidneys have reached their limit and can no longer reabsorb the glucose so it gets urinated out. So, if you are checking your blood sugar and it always says 150 or under but you still have excessive thirst and sweet smelling urine you should get some of the old fashioned color changing strips. They will change color to indicate your sugar level. It's obvious they aren't as accurate, but they will show you a good estimate of where your machine should be reading.

    December 23, 2010 at 10:45 | Report abuse | Reply
    • kenny

      It is wise to suppliment testing using urine test stick. If it change color it means your blood sugar is being exceeded, assuming you are not hypo due to your regular meal and that you have no symptom of hypo, such as sweating and confussion.

      December 25, 2010 at 08:59 | Report abuse |
  16. lorne

    to diosGX (and CNN)
    common you guys 'fess up. yours was the very first comment. it was pretty stoopid. nah, it was really stoopid. so i figure that your letter was a "plant" to invite a lot of comments from us here diabetics. right?
    strips empowers me by giving me the knowledge to know where i am at a particular time of the day, and therefore what i need to need to do in terms of my meds, my diet, and exercise . the reading also politely lets me know that i should not have cheated at dinner last night by having that extra piece of dessert.
    Abbott, shore would like to know how long ya knew about all this before your "voluntary recall". howz about a "voluntary refund" for us rubes you have possibly harmed? nah, ferget it, can't ruin the ol' bottom line can we? (rhetorical question- don't bother to reply.)

    December 23, 2010 at 10:50 | Report abuse | Reply
  17. Meag

    So I have been a TYPE ONE Diabetic for 6 years now. I have both gone into Diabetic Ketoacidosis, and had a grand mal seizure and stopped breathing from my lows. I am now also diagnosed with hypoglycemia unawareness (I do not feel any symptoms of low until I reach 40 or lower). I have seen both extremes of the diabetic spectrum and an VERY aware of how important control of your bloodsugar is. For all those who say that the margin is acceptable is obviously clueless. I don't know about the rest of you but if my test strips were recalled and I had ignorant fools writing on a blog telling the world that it is perfectly fine to use just the 'margin,' I would be livid. All those who think that 1.) You go into a coma/die at 40. 2.) 80 is a low number. 3.) Margin is okay 4.)It is your own fault for all diabetic related problems..you are dreadfully unaware. If you think any of those, stop commenting and do some research. This recall is life-threatening, coming from someone who knows exactly how life threatening this disease can be.;

    December 23, 2010 at 11:15 | Report abuse | Reply
  18. servantOfJC

    The ReliOn Ultima strips that I use are on the list. The hotline (800-448-5234) is quite busy and I got a rep on the phone after about 15 minutes. The rep offered to mail a replacement to my pharmacy within two days by Fedex. She asked me to discontinue using the old strips immediately and wait for a return label to mail ths old strips back to Abbott.

    I hope the news spreads to other patients who may have been affected by this recall. I called my doctor's office to let them know, but they are already aware of this news. Take care folks!

    December 23, 2010 at 11:24 | Report abuse | Reply
  19. redzoom

    I think the point is being missed here. How much of your life has Abbott stolen because you relied on these bad readings. I expect to see a hugh class action law suit. However, that will not give you back the time you have been robbed of.

    December 23, 2010 at 20:57 | Report abuse | Reply
  20. James

    I had had tests that show that i have a high blood sugar and I know have symptoms of having a high blood sugar but I am not officially diagnosed by my doctor as diabetic. Yet, when I cut down on my sugar intake, I feel much better. Is there such a thing as 'almost' oe semi diabetic?
    http://www.bloodtypechart.com

    December 26, 2010 at 04:37 | Report abuse | Reply
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