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Trinity Biotech

CLARK LABORATORIES, INC. · Model 2325601 · UDI-DI 05391516747066

GQX
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

Captia™ Varicella-Zoster Virus (VZV) IgG

Recalls

DateFirmReason
2012-05-29Clark Laboratories, Inc. (dba,Trinity Biotech USA)The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,

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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.