Reported Oct 3, 2012 · Terminated
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro…
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clark Laboratories, Inc. (dba,Trinity Biotech USA) · 2823 Girts Road · Jamestown, NY · 14701
Is this the product you have?
- Trinity Biotech, Captia VZV IgG
- Product code 232560096 Tests
- product code2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera
- Lot codes and dates
- Kit lot codes
2325600-5662325601-5662325600-5672325601-5672325600-568
- Kit lot codes
- Amount recalled
- 810 kits
Where it was sold
Why it was recalled
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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