FDA Medical Device Recalls (openFDA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA): Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- Recall number
- Z-2782-2016
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Product
- Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- Status
- Terminated
- Initiated
- 2016-07-11
- Posted
- 2016-09-12
- Terminated
- 2017-05-09
- Reason
- The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
- Root cause
- Nonconforming Material/Component
- Action
- Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.
- Quantity
- US: 6 kits, Foreign: 50 kits
- Distribution
- Distribution to US nationwide including California, and China (Hong Kong).
- Lot, serial or model codes
- Lot Number 2326060-043, Expiration Date 31 May 2017
- 510(k) numbers
- ["K140455"]
- PMA numbers
- not on file
- Product code
- PCL
- 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