D-10 Dual Program — Class III medical device recall Z-0965-2014
Terminated recall by Bio-Rad Laboratories, Inc., reported 2014-02-19, distributed nationwide. D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated
| Recall number | Z-0965-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Hercules, CA, United States |
| Recall initiated | 2013-11-22 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, IN, NZ |
| Lot numbers | 20030322, 20030337, 64000081, 64000331, 64000332, 64000888, 64001344, 64002239 |
| Model numbers | 220-0201 |
Product
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
Reason for recall
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
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-0965-2014. 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.