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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

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.
Recall Number Z-2445-2012
Classification Class III
Code Info Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Product Distributed Qty 810 kits
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.

Event Detail

Event Id 62440
Product Type Devices
Status Ongoing
Recalling Firm Clark Laboratories, Inc. (dba,Trinity Biotech USA)
City Jamestown
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.