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C3

RANDOX LABORATORIES LIMITED · Model CM3845 · UDI-DI 05055273201611

CZW Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
31
Facilities

Description

A Complement C3 test system is a device intended for the quantitative in vitro determination of Complement C3 concentration in serum

Recalls

DateFirmReason
2018-05-16Abbott Laboratories, IncAn update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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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.