Clark Laboratories, Inc. (dba,Trinity Biotech USA): Medical Device Recall in 2012 - (Recall #: Z-2445-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: May 29, 2012

Date Posted: October 3, 2012

Recall Number: Z-2445-2012

Event ID: 62440

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.

Status: Terminated

Product Quantity: 810 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated