FDAFDA · Food and drugs·Recall number Z-0625-2014
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) 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.
Published January 15, 2014 · Recall initiated: April 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
- Lot
- Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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