CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report

HbA1c Flex(R) reagent cartridge (K3105A recalled

Siemens Healthcare Diagnostics is recalling HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the, distributed nationwide in the US. The recall was initiated on 22 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13.

Quantity recalled11006 Total

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-0626-2014
FDA event ID: 65409
Recalling firm: Siemens Healthcare Diagnostics, Newark, DE
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2013
FDA classified: 3 Jan 2014
Reported: 15 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Insulin Pumps & Glucose Monitors

Timeline

22 Apr 2013	Recall initiated by company
3 Jan 2014	Classified by FDA	+256 days
15 Jan 2014	Published in enforcement report	+12 days

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

Reason for recall

Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.

Nationwide

Questions about this recall

Why was it recalled?

Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Which lots are affected?

Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13.

Where was it sold?

Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 65409

Reported	Class	Recall	Company	Reason	Where
15 Jan 2014	CLASS II	HB1C Flex(R) Reagent Cartridge (DF105A recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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