Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnost
FDA device recall Z-2445-2012 · posted 2012-09-24 · Terminated
Recall details
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GQX
- Quantity affected
- 810 kits
- Distribution
- Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
- Date initiated
- 2012-05-29
- Date posted
- 2012-09-24
- Date terminated
- 2016-05-24
- Location
- Jamestown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIRGO(R) VZV-IGG ELISA (K883427) | Electro-Nucleonics, Inc. | 1989-03-10 |