Z-1245-2013Class I

FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle...

Name: Z-1245-2013 FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle...
Creator: Abbott Diabetes Care, Inc.
Published: 2013-04-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-04-15 / Terminated / root cause: software

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc... on 2013-04-15. FDA classified it as Class I and gives the reason as "AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1245-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-15
Posted: 2013-05-09
Terminated: 2015-08-03
Recalling firm: Abbott Medical
Product: FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Root cause tag: software
FDA root cause: Software design
Action: Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.
Quantity in commerce: 335,273 meters; 209,336 remain at firm.
Distribution: Nationwide Distribution
Product codes and lots: Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-09

Product code NBW

K120568Class IIFreestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. / cleared 2012-03-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)