D-10" Hemoglobin Testing System — Class II medical device recall Z-1299-2014
Terminated recall by Bio-Rad Laboratories, Inc., reported 2014-04-02, distributed nationwide. On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previou
| Recall number | Z-1299-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Hercules, CA, United States |
| Recall initiated | 2014-02-27 |
| Classified | 2014-03-26 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HU, ID, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, MA, MX, MY, NG, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 483 instruments |
| Reason classes | software |
| Model numbers | 220-0220 |
Product
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
Reason for recall
On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
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-1299-2014. 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.