FDA Device recall Z-1208-2022
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
- FDA Device
- Class II
- ongoing
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000 by Bio Rad Laboratories, citing 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-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1208-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-07 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | AL, AR, AZ, CO, FL, GA, IA, IN, KS, KY, LA, MD, MN, MO, NC, NJ, NY, OH, OR, PR, SC, TN, UT, VA |
Product
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Reason
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.
Identifiers
| code_info | REF: 250-3020/Lot: AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085; REF: 250-3000, UDI/DI: 00847817008276, Lot/Exp…REF: 250-3020/Lot: AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085; REF: 250-3000, UDI/DI: 00847817008276, Lot/Expiry: 64442741/ 2/28/2023, 64444208/ 2/28/2023, 64444218/ 3/26/2023, 64444715/ 3/31/2023, 64452929/ 3/31/2023, 64452922/ 5/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2022%22
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