December 04, 2013
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FDA: FreeStyle, FreeStyle Lite test strips affected by recall

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Abbott has announced a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite blood glucose test strips in the United States due to inaccurately low blood glucose readings, according to a press release.

The results can occur when used with the FreeStyle blood glucose meter, FreeStyle Flash blood glucose meter or OmniPod insulin management system.

However, when the test strips are used with newer meters (ie, FreeStyle Freedom, FreeStyle Lite and FreeStyle Freedom Lite), the test results are not affected by this error, according to the release

The company has notified health care professionals, pharmacists and patients with diabetes about the recall; health care providers are encouraged to report adverse events related to this recall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting a report online or calling 1-800-332-1088. Lot numbers included in this recall are as follows:

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

For more information:

MedWatch: the FDA safety information and adverse event reporting program. Accessed Dec. 2, 2013.