FDA Medical Device Recalls (openFDA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA): 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.
- Recall number
- Z-2445-2012
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-05-29
- Posted
- 2012-09-24
- Terminated
- 2016-05-24
- Reason
- The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 810 kits
- Distribution
- Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
- Lot, serial or model codes
- Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
- 510(k) numbers
- ["K883427"]
- PMA numbers
- not on file
- Product code
- GQX
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28