FDA Medical Device Recalls (openFDA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA): Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
- Recall number
- Z-0819-2015
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Product
- Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
- Status
- Terminated
- Initiated
- 2014-11-17
- Posted
- 2014-12-16
- Terminated
- 2016-05-24
- Reason
- Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
- Root cause
- Under Investigation by firm
- Action
- Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
- Quantity
- Domestic: 9 kits; Foreign: 26 kits
- Distribution
- New York, Florida, Utah, and California plus foreign distribution to Spain and France
- Lot, serial or model codes
- Lot 033, expiry date 30 November 2014
- 510(k) numbers
- ["K904524"]
- PMA numbers
- not on file
- Product code
- LIP
- 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