FDA Device recall Z-0626-2014
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems by Siemens Healthcare Diagnostics, citing positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0626-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-22 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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.
Reason
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Identifiers
| code_info | Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:1210…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0626-2014%22
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