FDA Device recall Z-0965-2014
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette
- FDA Device
- Class III
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class III recall of D-10 Dual Program, which contains Update Kit D-10 A1c program diskette by Bio Rad Laboratories, citing 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 Exte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-22 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31…Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014 64000331 5/31/2014 64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014 ( 64002240 08/3112014 64002241 11/30/2014 |
|---|
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-0965-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.