Device product
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Z-2445-2012
Product summary
- Event
- Event 62440
- Status
- Terminated
- Classification
- Class III
- Quantity
- 810 kits
- Official record key
device-enforcement:Z-2445-2012
Official wording
Reason: The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Code information: Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Distribution pattern: Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Derived failure modes
-
Unknown
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.