Recall Z-2445-2012 ยท GQX Antiserum, Cf, Varicella-Zoster
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
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.
| Date | Sep 24, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. |
| Root cause | 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 | 810 kits |
| Distribution | Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883427 | VIRGO(R) VZV-IGG ELISA Electro-Nucleonics, Inc., Mar 10, 1989 |