FDA Device Intelligence
HomeEMD Millipore Corporation › Light Diagnostics VZV DFA Reagent

Light Diagnostics VZV DFA Reagent

EMD Millipore Corporation · Model 5094 · UDI-DI 04053252732638

GQX
10
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

VZV DFA Reagent

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,

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.