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Light Diagnostics™ Varicella- Zoster Virus DFA Kit

EMD Millipore Corporation · Model 3430 · UDI-DI 08436037124716

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

Description

Varicella- Zoster Virus DFA Kit

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.