Atellica IM Syph 10995675Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414599885), received between Jul 19, 2019 and Jul 19, 2019 — classified as 3 malfunctions.

2 other recalls cover devices cleared under the same FDA submission (K112343); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ATELLICA IM (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON BOTH ATELLICA IM SYSTEMS ON A DIFFERENT DATE AND THE RESULTS WERE (B)(6). THE INITIAL DETECTION OF TREPONEMAL ANTIBODIES AT THE EMERGENCY SERVICE WAS (B)(6). TESTING ON AN ALTERNATE METHOD YIELDED POSITIVE RESULTS. CONFIRMATORY TESTING WAS PERFORMED. THE TPHA RESULT WAS INDETERMINATE AND THE FTA RESULT WAS POSITIVE. THE RPR RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8808425 ↗
• MalfunctionJul 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ATELLICA IM SYPHILIS (SYPH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON BOTH ATELLICA IM SYSTEMS ON A DIFFERENT DATE AND THE RESULTS WERE (B)(6). THE INITIAL DETECTION OF TREPONEMAL ANTIBODIES AT THE EMERGENCY SERVICE WAS (B)(6). TESTING ON AN ALTERNATE METHOD YIELDED (B)(6) RESULTS. CONFIRMATORY TESTING WAS PERFORMED. THE TPHA RESULT WAS INDETERMINATE AND THE FTA RESULT WAS (B)(6). THE RPR RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM SYPHILIS (SYPH) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8808420 ↗
• MalfunctionJul 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ATELLICA IM SYPHILIS (SYPH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON BOTH ATELLICA IM SYSTEMS ON A DIFFERENT DATE AND THE RESULTS WERE (B)(6). THE INITIAL DETECTION OF TREPONEMAL ANTIBODIES AT THE EMERGENCY SERVICE WAS (B)(6). TESTING ON AN ALTERNATE METHOD YIELDED (B)(6) RESULTS. CONFIRMATORY TESTING WAS PERFORMED. THE TPHA RESULT WAS INDETERMINATE AND THE FTA RESULT WAS (B)(6). THE RPR RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM SYPHILIS (SYPH) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8808410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112343. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2021 · Apr 21, 2021 · Open, Classified
  Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma
• Z-2228-2012 · Jul 17, 2012 · Terminated
  Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoass