Home / Recalls / Clark Laboratories, Inc. (dba,Trinity Biotech USA) / Z-2445-2012

Z-2445-2012 Class III Terminated

Recalled by Clark Laboratories, Inc. (dba,Trinity Biotech USA) — Jamestown, NY

Recall Details

Product Type
Devices
Report Date
October 3, 2012
Initiation Date
May 29, 2012
Termination Date
May 24, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
810 kits

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.

Reason for Recall

The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.

Distribution Pattern

Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.

Code Information

Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568

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