Trinity Biotech 800-970Recalls & reported problems
Clark Laboratories, Inc. · CAPTIA™Syphilis (T. Pallidum)-G · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391516744829), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2018Off-Label Use
BIO-RAD TECHNICAL SUPPORT WAS CONTACTED ON (B)(6) 2018 BY A BIO-RAD ACCOUNT MANAGER ON BEHALF OF THE CUSTOMER AT CERRITOS REFERENCE LAB. THE CUSTOMER HAD A QUESTION AS TO HOW THEY SHOULD BE REPORTING RESULTS FOR CAPTIA¿ (B)(6). THE CUSTOMER HAD SWITCHED FROM RPR TESTING TO CAPTIA¿ (B)(6) IGG TESTING DURING THE THIRD WEEK OF (B)(6) 2018, AND THE CUSTOMER WAS REPORTING THE CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG RESULTS OUT AS RPR RESULTS. BIO-RAD TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THEY HAVE BEEN REPORTING OUT THE RESULTS INCORRECTLY, AND PROVIDED THE INFORMATION AS TO HOW THE RESULTS SHOULD BE REPORTED. AS PART OF THE INCIDENT INVESTIGATION BIO-RAD TECHNICAL SUPPORT DISCOVERED THAT THE CUSTOMER WAS RUNNING CAPTIA¿ (B)(6) IGG FOR TESTS THAT WERE ORDERED AS RPR, AND THAT THE TESTS WERE REPORTED AS RPR. THE CUSTOMER REPORTED THAT THEY HAVE SENT A LETTER OUT INFORMING ALL OF THEIR CLINICS OF THE SITUATION, AND THAT THE CUSTOMER WILL TAKE CORRECTIVE ACTION TO RESOLVE THE INCIDENT. THIS INCIDENT IS USER ERROR AS THE CUSTOMER DID NOT PERFORM THE TEST THAT WAS ORDERED BY THE PHYSICIAN, AND THE CUSTOMER REPORTED OUT RESULTS INCORRECTLY. BECAUSE RESULTS WERE REPORTED OUT INCORRECTLY THER
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7626067 ↗
Other Enzyme Linked Immunoabsorption Assay, Treponema Pallidum devices
- IMMULITE® 2000 Systems SYP Syphilis Screen 10471981Siemens Healthcare Diagnostics Products Ltd · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM1 recall0 reports
- Elecsys Syphilis 09015051190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM28 reports
- VITROS 6177333Ortho Clinical Diagnostics · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM13 reports
- Elecsys Syphilis 09014977190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM13 reports
- Elecsys Syphilis 07251378190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM7 reports
- Elecsys Syphilis 06923348190Roche Diagnostics GmbH · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM7 reports
- Atellica IM Syph 10995675Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM3 reports
- ADVIA Centaur® SYPH 10492493Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.