Bio-Rad recalls specific lots of VARIANT nbs Sickle Cell Program Resin Update CD-ROM (250-3020) that overwrite custom lab settings during updates, risking incorrect sample results. Affected units include certain reorder packs with specific lot numbers.
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.
Bio-Rad is recalling specific lots of VARIANT nbs Sickle Cell Program Resin Update CD-ROM software (model 250-3020) that can overwrite custom lab settings when updated. This may cause incorrect results for samples if the lab's custom patterns differ from default settings.
The CD-ROM software updates can reset custom lab settings to default values, potentially causing samples to be analyzed with incorrect patterns. This could lead to inaccurate results if the lab's custom patterns differ from the default settings used during validation.
Laboratories using the VARIANT nbs Sickle Cell Program Reorder Pack (model 250-3000) with specific lot numbers are most at risk. The recall affects only those who have the recalled CD-ROM software installed.
Check for the Resin UPDATE CD-ROM (model 250-3020) inside the VARIANT nbs Sickle Cell Program Reorder Pack (model 250-3000). Affected units have specific lot numbers: AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085.
Look for the lot number on the CD-ROM packaging, which should be one of AX90085, AY90085, AZ90085, BB90085, CB90085, or DB90085.
The CD-ROM software can overwrite custom lab settings during updates, potentially causing incorrect sample results if the lab's custom patterns differ from default settings.
The official recall notice does not specify a remedy or action for affected units.
Labs using the VARIANT nbs Sickle Cell Program Reorder Pack (model 250-3000) with specific lot numbers listed in the recall are affected.
We’ve drafted a message you can send Bio-Rad to request your refund or repair — edit it as you like.
Subject: Recall Z-1208-2022 — Bio-Rad Bio-Rad Hello, I own a Bio-Rad that is covered by recall Z-1208-2022 from Bio-Rad. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
