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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568 Class III The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. 810 kits Z-2445-2012