CLASS I Device recall · Reported 15 May 2013 · FDA Enforcement Report

FreeStyle InsuLinx Blood Glucose Monitoring System recalled

Abbott Diabetes Care is recalling FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only, distributed nationwide in the US. The recall was initiated on 15 Apr 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Quantity recalled335,273 meters; 209,336 remain at firm.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1245-2013
FDA event ID: 64876
Recalling firm: Abbott Diabetes Care, Alameda, CA
Classification: Class I
Status: Terminated
Recall initiated: 15 Apr 2013
FDA classified: 9 May 2013
Reported: 15 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Labeling Errors
Device type: Insulin Pumps & Glucose Monitors

Timeline

15 Apr 2013	Recall initiated by company
9 May 2013	Classified by FDA	+24 days
15 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

Which lots are affected?

Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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