Lower risk Medical device recall · FDA · Published April 7, 2022

Bio-Rad VARIANT nbs Sickle Cell Program CD-ROM Update Causes Custom Settings Overwrite

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1208-2022Medical device Bio-Rad ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBio-Rad Laboratories, Inc.4000 Alfred Nobel Dr · Hercules, CA 94547-1803

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/60835-bio-rad-variant-nbs-sickle-cell-program-cd-rom-update.

Source Summary by GovInfoNow · govinfonow.com/recall/60835-bio-rad-variant-nbs-sickle-cell-program-cd-rom-update · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1208-2022

Cite this page

“Bio-Rad VARIANT nbs Sickle Cell Program CD-ROM Update Causes Custom Settings Overwrite.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60835-bio-rad-variant-nbs-sickle-cell-program-cd-rom-update. Based on FDA recall #Z-1208-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2022%22&limit=1).

The FDA announced on April 7, 2022, that Bio-Rad Laboratories is recalling specific lots of the VARIANT nbs Sickle Cell Program Reorder Pack due to software errors. The hazard involves custom settings being overwritten by default parameters during updates.

How to tell if you have it

Brand: Bio-Rad
Product: VARIANT nbs Sickle Cell Program Reorder Pack, REF: 250-3000
Component: Resin UPDATE CD-ROM, REF: 250-3020
REF 250-3020 Lot Codes: AX90085, AY90085, AZ90085, BB90085, CB90085, DB90085
REF 250-3000 Lot/Expiry Codes: 64442741/2/28/2023, 64444208/2/28/2023, 64444218/3/26/2023, 64444715/3/31/2023, 64452929/3/31/2023, 64452922/5/31/2023
Distribution: US states AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH, OR, SC, IA, AL, UT, PR; Canada, Spain, France, Italy, India, Vietnam, Philippines

The hazard

According to the FDA, the software causes customized settings in the Setup/Test/Data Setup and Setup/Test/Pattern Setting subscreens to be overwritten with default settings when the Update Kit procedure is performed. This risk arises because customer custom pattern settings may differ from default settings, potentially resulting in different patterns being assigned to validated samples. The firm initiated this recall following complaints from four customers who experienced these issues.

Context

GovInfoNow's records show Bio-Rad Laboratories has 12 other recalls on record since April 2, 2018. Other recent recalls of similar products include the Bio-Rad Platelia Toxo IgM Kit Recall (May 30, 2025) and the Bio-Rad BioPlex 220 Recall (Feb. 28, 2023).

How to tell if you have this one

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.

Brand
Bio-Rad
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check CD-ROM Lot Number
Look for the lot number on the CD-ROM packaging, which should be one of AX90085, AY90085, AZ90085, BB90085, CB90085, or DB90085.

Where it went and when

Where it was distributed

Distributed in 23 states and Puerto Rico, and outside the U.S.

FDA distribution: “US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH, OR, SC, IA, AL, UT, PR OUS: Canada, Spain, France, Italy, India, Vietnam, Philippines” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Apr 7, 2022Firm started the recall
May 28, 2022FDA classified it Class II
Jun 8, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60835-bio-rad-variant-nbs-sickle-cell-program-cd-rom-update">Bio-Rad VARIANT nbs Sickle Cell Program CD-ROM Update Causes Custom Settings Overwrite (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1208-2022 (April 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1208-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.