ARCHITECT 8D06-13Recalls & reported problems
Abbott GmbH · ARCHITECT Syphilis TP Controls · 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 00380740103545), received between Oct 22, 2018 and Oct 22, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Eye Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2018Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT A MALE EMPLOYEE DROPPED A SAMPLE CUP WITH ARCHITECT (B)(6) CONTROL IN IT AND SOME OF THE FLUID SPLASHED INTO HIS EYE. THE EMPLOYEE FLUSHED HIS EYE WITH WATER. THE EMPLOYEE SAW HIS PHYSICIAN BUT NO ADDITIONAL TREATMENT WAS GIVEN. THE EMPLOYEE WAS NOT WEARING ANY PERSONNEL PROTECTIVE EYE WEAR. THERE WAS NO REPORTED IMPACT TO EMPLOYEE MANAGEMENT.
Patient problems: Eye Injury
MAUDE report 7990693 ↗
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.