Devices

Device Recall Captia VZV IgG

Model / Serial
Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Product Description
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.
Manufacturer
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
1 Event
- Recall of Device Recall Captia VZV IgG

Manufacturer

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Manufacturer Address
Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
Manufacturer Parent Company (2017)
Trinity Biotech plc
Source
USFDA

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