CLASS II ONGOING Device recall · Reported 8 Jun 2022 · FDA Enforcement Report
Resin Update Cd-rom recalled by Bio-Rad Laboratories
Bio-Rad Laboratories is recalling Resin Update Cd-rom, distributed in 24 states. The recall was initiated on 7 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1208-2022
- FDA event ID
- 90027
- Recalling firm
- Bio-Rad Laboratories, Hercules, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2022
- FDA classified
- 28 May 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2022 | Recall initiated by company | |
| 28 May 2022 | Classified by FDA | +51 days |
| 8 Jun 2022 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Where it was distributed
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
AlabamaArkansasArizonaColoradoFloridaGeorgiaIowaIndianaKansasKentuckyLouisianaMarylandMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOregonPuerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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