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Sofia

QUIDEL CARDIOVASCULAR INC. · Model 20352 · UDI-DI 30014613338772

LQP Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
18
Facilities

Description

Sofia 2 Campylobacter FIA

Recalls

DateFirmReason
2002-07-15Remel, Inc.A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

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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.