FDAApril 7, 2022device

Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

00847817008276

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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