Posted from: Tuesday, December 10, 2013 - 04:24 PM - Present

DRUG RECALL - FreeStyle and FreeStyle Lite Blood Glucose Test Strips (used to test blood glucose levels in Diabetics)

On November 27, 2013, Abbott issued a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose test strips.  The recall is due to the test strips producing incorrect low blood glucose results when testing with the FreeStyle® Blood Glucose Meter, the FreeStyle® Flash Blood Glucose Meter, and/or the OmniPod® Insulin Management System. 

The recalled lots are as follows:

1281732

1363321

1367917

1283345

1365056

1373262

1283603

1365920

1374907

1285007

1365934

1366515

1366111

1366337

1366006

1363015

1366347

1350414

1363109

1365921

 

FreeStyle® and FreeStyle Lite® Blood Glucose test strips are used to test blood glucose levels in diabetics.

There have not been any adverse events related to this recall, however; when glucose levels are high and go untreated, patients may not seek the proper treatment for extreme hyperglycemia which can potentially lead to serious injury.

For replacement test strips, please call Abbott’s Diabetes Care customer service at (888) 736-9869. Abbott will replace the affected test strips at no cost.

Members using mail order should be aware that Benecard Central Fill did not dispense any of the affected lots.

Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

 

Online: www.fda.gov/medwatch/report.htm

Regular Mail:  use postage-paid FDA form 3500 available at:  www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 

Fax: 1-800-FDA-0178

Last Updated Friday, December 08, 2017 - 09:01 PM.