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.
This recall has been terminated (originally issued September 24, 2012).
- Recall Initiated
- May 29, 2012
- Posted
- September 24, 2012
- Terminated
- May 24, 2016
- Recall Number
- Z-2445-2012
- Quantity
- 810 kits
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Lot / Code Info
Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
Root 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.