Z-2445-2012 Class III Terminated
FDA device recall Z-2445-2012 was initiated by Clark Laboratories, Inc. (dba,Trinity Biotech USA) on May 29, 2012 and is designated Class III. 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. The recall status is terminated (terminated May 24, 2016). Affected quantity: 810 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2012
- Initiation Date
- May 29, 2012
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 810 kits
Product Description
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.
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 Pattern
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Code Information
Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568