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U.S. Department of Health and Human Services

Class 3 Device Recall Captia VZV IgG

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  Class 3 Device Recall Captia VZV IgG see related information
Date Initiated by Firm May 29, 2012
Date Posted September 24, 2012
Recall Status1 Terminated 3 on May 24, 2016
Recall Number Z-2445-2012
Recall Event ID 62440
510(K)Number K883427  
Product Classification Antiserum, cf, varicella-zoster - Product Code GQX
Product 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.
Code Information Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Recalling Firm/
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
2823 Girts Road
Jamestown NY 14701
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 810 kits
Distribution Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GQX and Original Applicant = ELECTRO-NUCLEONICS, INC.