HbA1c Flex(R) reagent cartridge recall
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C)…
Why was HbA1c Flex(R) reagent cartridge recalled?
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C)…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 11006 Total
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)