Class II — Bio-Rad Laboratories, Inc.
| Recalling firm | Bio-Rad Laboratories, Inc. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 165 in US, 200 Internationally |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK. |
| Initiated | 2015-12-15 |
| Classified | 2016-01-27 |
| Terminated | 2016-05-02 |
| Recall number | Z-0695-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bio-Rad Laboratories, Inc. (Z-0695-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72927/
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