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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD1412-1 · UDI-DI 00894175000015
10
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities
Description
AccuDiag ™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-05-29 | Clark 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. |
| 2008-08-27 | Calbiotech Inc | The 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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