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BioPlex 2200

BIO-RAD LABORATORIES, INC. · Model SW4.1V1 · UDI-DI 00847865013000

MVMMST
10
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities

Description

Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1

Recalls

DateFirmReason
2019-04-03Bio-Rad LabsAn elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th

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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.