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MicroVue

QUIDEL CORPORATION · Model CIC-C1q EIA · UDI-DI 30014613335535

DAK Prescription
10
510(k) clearances
0
Adverse events
3
Recalls
9
Facilities

Description

MicroVue CIC-C1q EIA

Recalls

DateFirmReason
2017-04-04Diagnostic Hybrids, Inc.There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
2015-11-03Diagnostic Hybrids, Inc.A component of the kit was found to contain bacterial contamination.
2009-10-28Inova Diagnostics IncorporatedThe recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an EL

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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.