HB1C Flex — Class II medical device recall Z-0625-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-01-15, distributed nationwide. Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" f
| Recall number | Z-0625-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-04-22 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 11,006 total |
| Reason classes | potency |
| Lot numbers | GA3099, GA3113, GA3134, GA3141, GA3162, GA3169, GA3197, GA3232, GA3247, GA3267, GB3211, GB3281, GC3302 |
| Model numbers | DF105A |
| Expiration dates | 2013-04-09, 2013-04-23, 2013-05-14, 2013-05-21, 2013-06-11, 2013-06-18, 2013-07-16, 2013-07-30, 2013-08-20, 2013-09-04, 2013-09-24, 2013-10-08, 2013-10-29 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0625-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.