Monday, January 03, 2011

Glucose Test Strip Recall, December 2010





Abbott Labs Blood Glucose Test Strip Recall

Abbott Laboratories produces a variety of blood glucose test systems--most of their strips have names that include Precision, Optium, ReliOn and Medisense.  A recall of 359 million of Abbott's blood glucose test strips (359 lots) was announced in December of 2010.  Abbott reports that the affected test strips, which were produced from January through September 2010, are reading blood glucose results incorrectly.  The fault is not with the glucometer, but with the test strips that are included in the recall. 

What is wrong with the strips?

Abbott's press release warns that the faulty strips can cause a blood glucose reading that is too low.  A press release from the FDA further explains that the strips do not absorb enough blood to correctly read the true blood glucose result. A low reading can result in a false sense of security--this is particularly dangerous for individuals with Type 1 Diabetes who rely on accuracy in order to keep from experiencing diabetic ketoacidosis (dka) when blood glucose goes too high.  Harm can result when an individual tries to raise their blood sugar to a higher level (because the reading on the machine is falsely low), or an individual may delay properly intervening to correct a blood glucose that is actually too high.

Prolonged storage and/or exposure to warm temperatures pose an even greater risk of these strips producing a false reading.

What lot numbers are included in the recall?

MediSense® Optium™ Blood Glucose Electrodes

45001A133, 45001A137, 45001A226, 45001A252, 45001A257, 45001A277, 45001A285, 45001A817, 45001A835, 45001A921, 45001C001

OptiumEZ Blood Glucose Test Strips

45358, 45369, 45377, 45504, 45677, 45678, 45681, 45789, 45841, 45848, 45849, 45999, 46000, 46008, 46061, 46067, 46102, 46104, 46117, 46159, 46179, 46201, 46202, 46211, 46230, 46247, 46311, 46312, 46341, 46368, 46369, 46371, 46395, 46399, 46401, 46436

Precision G3b Smartblue Blood Glucose Test Strips

45001A710

ReliOn® Ultima Blood Glucose Test Strips

45358, 45369, 45377, 45379, 45466, 45504, 45511, 45608, 45613, 45641, 45642, 45644, 45672, 45674, 45675, 45676, 45677, 45721, 45734, 45736, 45739, 45742, 45743, 45789, 45790, 45800, 45801, 45840, 45841, 45849, 45850, 46008, 46009, 46061, 46067, 46069, 46072, 46103, 46105, 46148, 46201, 46202, 46214, 46215, 46232, 46313, 46332, 46336, 46338, 46341, 46368

MediSense® Optium™ Blood Glucose Test Strips

45001A159, 45001A195, 45001A228, 45001A233, 45001A236, 45001A243, 45001A247, 45001A249, 45001A250, 45001A255, 45001A279, 45001A285, 45001A295, 45001A298, 45001A306, 45001A317, 45001A318, 45001A327, 45001A346, 45001A398, 45001A449, 45001A469, 45001A578, 45001A693, 45001A697, 45001A747, 45001A790, 45001A795, 45001A839, 45001A917

Optium™ Blood Glucose Test Strips

45001A484, 45001A486, 45001A512, 45001A514, 45001A517, 45001A519, 45001A527, 45001A541, 45001A544, 45001A552, 45001A558, 45001A564, 45001A572, 45001A598, 45001A665, 45001A677, 45001A709, 45001A713, 45001A732, 45001A771, 45001A819, 45001A852,

45455, 45516, 45708, 45709, 45737, 45738, 45777, 45778, 45783

Precision Xceed Pro® Blood Glucose Test Strips

44535H, 44545H, 44565H, 445A5H, 44645H, 44665H, 446E5H, 44725H, 44745H, 44755H, 44925H, 44945H, 44945H, 44975H, 44995H, 449A5H, 44A15H, 44A35H, 44A75H, 44A85H, 44C65H, 44C75H, 44CE5H, 44CH5H, 44CP5H, 44CR5H, 45025H, 45035H, 450A5H, 450C5H

Precision® Point of Care Blood Glucose Test Strips

45515, 45517, 45701, 45791, 45963, 45964, 46367


If Your Current Strips are Part of the Recall:

Get free replacement strips.  Call Abbott Diabetes Care Customer Service for replacement of your affected strips at no charge: 1-800-448-5234.  Abbott will send you unaffected Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips.
  • While waiting for the replacement strips to arrive, use an alternate method to measure blood glucose (such as a different test system) or purchase at least two weeks worth of new, unaffected strips while waiting for replacement strips.
  • When purchasing from a store or online, be sure you are purchasing strips that are not included in the recall.  You can ask your pharmacist to make certain that the strips they have available are from  unaffected lots.
What to do until you get new strips

If the only test strips available to you are from affected lots, do not stop testing your blood glucose. But do take the following two precautions to reduce the chance of erroneous reading:
    • Precaution 1: Check the amount of time it takes for your blood glucose meter to start the “countdown” after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip.
      • If your meter takes longer than five (5) seconds to start the countdown that test strip is defective and the result should not be used.
      • Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.
    • Precaution 2: If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.
Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).
  • Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
  • Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.
In Health Care Settings (Hospitals, Nursing Homes, Doctor's Offices)  

Precision Xceed Pro is a point-of-care glucometer used in some health care settings. If your facility uses this system, check the lot numbers of your test strips against the recalled lots (above).





If your facility has affected strips,the FDA recommends the followingIf available, immediately switch to using test strips from lots that are not part of the recall.
  • If your facility only has test strips that are part of the recall, switch to an alternate blood glucose system (if you have one readily available) and stop using the Precision Point of Care system until you obtain strips that are not part of the recall.
  • If your facility only has test strips that are part of the recall and you do not have an alternate blood glucose testing system available, the FDA recommends the following procedures:
    1. Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
    2. Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
    3. When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
      • i. Note the specific lot number of that test strip.
      • ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185.
      • iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.
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