D-10 Rack Loader — Class II medical device recall Z-0695-2016
Terminated recall by Bio-Rad Laboratories, Inc., reported 2016-02-03, distributed nationwide. On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in
| Recall number | Z-0695-2016 |
|---|---|
| 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 | 2015-12-15 |
| Classified | 2016-01-27 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2016-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, ES, FR, GB, GR, IL, IN, IT, MY, NO, NZ, PL, PT, RU, SE, TH |
| Model numbers | 220-0600 |
Product
D-10 Rack Loader; Model Number 220-0600; Hematology: 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, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
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-0695-2016. 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.