Reported Jun 8, 2022 · Ongoing
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Bio-Rad Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories, Inc. · 4000 Alfred Nobel Dr · Hercules, CA · 94547-1803
Is this the product you have?
- Resin UPDATE CD-ROM
- REF250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack
- REF250-3000
- Lot codes and dates
- REF
250-3020/Lot: AX90085AY90085AZ90085BB90085CB90085DB90085
- REF250-3000
- UDI/DI00847817008276
- Lot/Expiry
64442741/ 2/28/202364444208/ 2/28/202364444218/ 3/26/202364444715/ 3/31/202364452929/ 3/31/202364452922/ 5/31/2023
- REF
- Amount recalled
- 1893
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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