Trinity Biotech recall
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the…
Why was Trinity Biotech recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
- Product
- Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the…
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Quantity
- 810 kits
- Distribution
- Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
- Recall date
- October 3, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)