| Class 3 Device Recall Captia VZV IgG | |
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
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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/ Manufacturer |
Clark Laboratories, Inc. (dba,Trinity Biotech USA) 2823 Girts Road Jamestown NY 14701
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For Additional Information Contact | 716-483-3851 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = GQX
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