Z-1258-2011

FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test...

Name: Z-1258-2011 FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test...
Creator: Abbott Diabetes Care, Inc.
Published: 2009-03-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-03-13 / Terminated

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite... on 2009-03-13. The reason FDA records is "Product dispositioned for destruction was potentially diverted to end users". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1258-2011
Status: Terminated
Initiated: 2009-03-13
Posted: 2011-02-15
Terminated: 2011-02-15
Recalling firm: Abbott Medical
Product: FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are intended for use in the home and in professional settings to monitor blood glucose levels.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Product dispositioned for destruction was potentially diverted to end users.
FDA root cause: Other
Action: The firm, Abbott Diabetes Care (ADC), will be posting notification on its Abbott Diabetes Care website. Also, the firm issued an "IMPORTANT: MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2009, to customers ( registered users of Free Style, Free Style Flash, FreeStyle Freedom or Free Style Navigator). For foreign consignees/customers, the firm has issued communication worldwide. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please check the lot number on the test strip carton or vial for the affected product number; if found, discontinue use and call the ADC Customer Care line at: 1-800-310-1500 and the ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent. If you have any questions, please call ADC Customer Care line at 1-800-310-1500.
Quantity in commerce: 1860 units
Distribution: The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consignees.
Product codes and lots: Part number/Lot or Serial Number/Expiration dates: 70345-02, 70468-1/0803221/Feb 2010; 70468-05/0802523/Jan 2010; 70344-02/0802832, 0802823, 0802422/JAN 2010, 70827-01/0817617/Jun 2010; 70468-04/0718730/ July 2009; 70817-01/0812304/May 2010

Product code NBW

K051839Class IIFree-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. / cleared 2006-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)