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VARIANT nbs

BIO-RAD LABORATORIES, INC. · Model 250-3003 · UDI-DI 00847817008306

GKA
1
510(k) clearances
2
Adverse events
10
Recalls
10
Facilities

Description

VARIANT nbs Sickle Cell Program Analytical Cartridge

Recalls

DateFirmReason
2022-04-07Bio-Rad Laboratories, Inc.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 #250-3
2020-10-09Primus CorporationThe product did not receive pre-market approval or clearance.
2018-11-01Clark Laboratories, Inc. (dba,Trinity Biotech USA)lack of 510K
2018-11-01Clark Laboratories, Inc. (dba,Trinity Biotech USA)lack of 510K
2018-11-01Clark Laboratories, Inc. (dba,Trinity Biotech USA)lack of 510K
2018-11-01Clark Laboratories, Inc. (dba,Trinity Biotech USA)lack of 510K
2018-11-01Clark Laboratories, Inc. (dba,Trinity Biotech USA)lack of 510K
2010-04-22Bio-Rad Laboratories IncThe presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
2010-04-14Bio-Rad Laboratories IncThe affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update
2004-09-14PerkinElmer LAS IncThe product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the corr

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.