Recall Z-2445-2012
Clark Laboratories, Inc. (dba,Trinity Biotech USA) · initiated May 29, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2445-2012
- Initiated
- May 29, 2012
- Posted by FDA
- September 24, 2012
- Terminated
- May 24, 2016
- Product code
- GQX – Antiserum, Cf, Varicella-Zoster
- Quantity
- 810 kits
- Distribution
- Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA), Jamestown, NY