Trinity Biotech 2329360Recalls & reported problems
Clark Laboratories, Inc. · CAPTIA™ NMT Syphilis IgM · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391516745048), received between May 18, 2021 and May 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2021Component Misassembled; Unclear Information; Component Misassembled; Unclear Information
A CUSTOMER COMPLAINT WAS RECEIVED STATING THAT THE LABELS FOR THE POSITIVE AND NEGATIVE CONTROLS WERE ON THE WRONG BOTTLES. THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE CONTROLS WHICH CONFIRMED THE KIT THEY HAD RECEIVED DID HAVE THE CONTROLS LABELLED INCORRECTLY. THE CUSTOMER FOUND THE ERROR PRIOR TO USING THE KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11841154 ↗
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.