FDA: Abbott Recalls Certain FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the U.S.

freestyle-blood-glucose-strips-recallAbbott Labs just issued a recall of some of its FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States, according to the U.S. Food and Drug Administration (FDA).

The recall involves 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips, which might produce erroneously low blood glucose results when used with the  “FreeStyle® Blood Glucose Meter,” the “FreeStyle® Flash Blood Glucose Meter,” or the OmniPod® Insulin Management System. Neither the “FreeStyle® Blood Glucose Meter” nor the “FreeStyle® Flash Blood Glucose Meter” have been in production since 2010.

When the FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips are used with the newer FreeStyle brand meters, including the FreeStyle® Freedom Blood Glucose Meter, the FreeStyle Lite® Blood Glucose Meter, and the FreeStyle Freedom® Lite Blood Glucose Meter, blood glucose test results are not affected. Also, testing with the FreeStyle InsuLinx® Blood Glucose Meter is not affected by this action because the FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips.

The recalled test strips are from lots with expiration dates from between May 2014 and March 2015, and include:

  • 1281732
  • 1283345
  • 1283603
  • 1285007
  • 1366111
  • 1363015
  • 1363109
  • 1363321
  • 1365056
  • 1365920
  • 1365934
  • 1366337
  • 1366347
  • 1365921
  • 1367917
  • 1373262
  • 1374907
  • 1366515
  • 1366006
  • 1350414

Abbot Labs is notifying healthcare professionals, pharmacies, distributors, and customers about the recall. Customers who are affected by this action are instructed to call Abbott’s diabetes care customer service, toll-free, at 1.888.736.9869 for a replacement of the affected test strips at no charge.

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