Resin UPDATE CD-ROM — Class II medical device recall Z-1208-2022
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2022-06-08, distributed in AL, AR, AZ, CO, FL, GA, IA, IN…. The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 25
| Recall number | Z-1208-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Hercules, CA, United States |
| Recall initiated | 2022-04-07 |
| Classified | 2022-05-28 |
| Reported by FDA | 2022-06-08 |
| Distributed | AL, AR, AZ, CO, FL, GA, IA, IN, KS, KY, LA, MD, MN, MO, NC, NJ, NY, OH, OR, PR, SC, TN, UT, VA |
| Countries outside the US | CA, ES, FR, IN, IT, PH, VN |
| Quantity | 1,893 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00847817008276 |
| Lot numbers | 64442741, 64444208, 64444218, 64444715, 64452922, 64452929, AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085 |
| Model numbers | 250-3000, 250-3020 |
Product
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Reason for recall
The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CD¿ROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.
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-1208-2022. 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.