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 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. |
| 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. |
| Quantity | 483 instruments in US. OUS to be determined. |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezuela, Colombia, Brazil, Jamaica, Austria, Switzerland, France, Germany, Greece, Portugal, Spain, Italy, UK, Belgium, Sweden Norway, Finland ,Israel/Palestine, Tunisia, Algeria, Egypt, ,Morocco, Jordan,… |
| Initiated | 2014-02-27 |
| Classified | 2014-03-26 |
| Terminated | 2014-06-04 |
| Recall number | Z-1299-2014 |
| 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-1299-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67624/
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