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Bio-Rad Laboratories, Inc. Recall 90027

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

Bio-Rad Laboratories, Inc. Recall 90027 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1208-2022
Event ID90027
Event DescriptionResin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Product TypeDevices
DistributionUS: 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
Quantity1893
Recall ReasonThe 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 Classification20220608
Device Code InfoREF: 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
Center Classification Date20220528
Recall Initiation Date20220407
Recalling FirmBio-Rad Laboratories, Inc.
Initial Notification Letter
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