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.
FDA Recall Z-2445-2012 · Posted 2012-09-24
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Recalling FirmClark Laboratories, Inc. (dba,Trinity Biotech USA)
Recall StatusTerminated
Product CodeGQX
Date Initiated2012-05-29
Date Terminated2016-05-24
Product Quantity810 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.
Firm Action
Trinity Biotech sent a "PRODUCT RECALL LETTER" dated May 29, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Fax Back Form was included in the letter for customers to complete and return via fax to (716) 488-1990. Customers were instructed to discard any of the affected product. Contact the Trinity Biotech Help Desk at 800-325-3424, option 2 for questions regarding this recall.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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