FDAFDA · Food and drugs·Recall number Z-2445-2012
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.
Published October 3, 2012 · Recall initiated: May 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Distributor
- Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
- Lot
- Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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