CLASS I Device recall · Reported 26 Mar 2014 · FDA Enforcement Report

FreeStyle Flash Blood Glucose Monitors System recalled

Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors System, distributed nationwide in the US. The recall was initiated on 19 Feb 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesCatalog Number 17002 NDC 99073-0170-02. All serial numbers

Quantity recalled25,203 units

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-1212-2014
FDA event ID: 67472
Recalling firm: Abbott Diabetes Care, Alameda, CA
Classification: Class I
Status: Terminated
Recall initiated: 19 Feb 2014
FDA classified: 18 Mar 2014
Reported: 26 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Insulin Pumps & Glucose Monitors

Timeline

19 Feb 2014	Recall initiated by company
18 Mar 2014	Classified by FDA	+27 days
26 Mar 2014	Published in enforcement report	+8 days

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

Reason for recall

Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.

Product as listed by the FDA

FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number 17002 NDC 99073-0170-02. All serial numbers

Where was it sold?

Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

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.

Other products in this recall event

1 other product · FDA event 67472

This product is part of a recall event; the main page for the event is FreeStyle Blood Glucose Monitors System recalled by Abbott Diabetes Care.

Reported	Class	Recall	Company	Reason	Where
26 Mar 2014	CLASS I	FreeStyle Blood Glucose Monitors System recalled by Abbott Diabetes Care	Abbott Diabetes Care	Labeling Errors	Nationwide

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