ADVIA Centaur® SYPH 10492493Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414580173), received between Jun 9, 2017 and Nov 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

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.

• MalfunctionNov 27, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS AN OBSERVATION OF A FALSE NEGATIVE (NON-REACTIVE) ADVIA CENTAUR XP SYPHILIS (SYPH) RESULT FOR A PATIENT SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL NON-REACTIVE RESULT WAS OBTAINED FOR A 49-YEAR-OLD FEMALE PATIENT. THIS INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS REPEATED ON THE ORIGINAL ADVIA CENTAUR ANALYZER AND OBTAINED A SIMILAR NON-REACTIVE RESULT. THE SAMPLE WAS THEN TESTED ON AN ALTERNATE METHOD AND OBTAINED A REACTIVE (POSITIVE) RESULT, WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). FOR TROUBLESHOOTING PURPOSE, THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER AND A REACTIVE RESULT WAS OBTAINED. T. PALLIDUM PARTICLE AGGLUTINATION [TPPA] AND RAPID PLASMA REAGIN (RPR) RESULTS ON THIS SAMPLE WERE ALSO REACTIVE. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665784 ↗
• MalfunctionJun 3, 2021False Negative Result; Off-Label Use; False Negative Result; Off-Label Use

  DISCORDANT, FALSE NONREACTIVE ADVIA CENTAUR XPT SYPHILIS (SYPH) REPEAT RESULTS WERE OBTAINED FROM A REHYDRATED BLOOD SPOT SAMPLE AFTER AN INITIAL SYPH REACTIVE RESULT. THE NONREACTIVE REPEAT RESULTS WERE TESTED WITH A DIFFERENT REHYDRATED BLOOD SPOT SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING WITH AN ALTERNATE RPR (NON-TREPONEMAL) TEST METHOD ON ANOTHER REHYDRATED BLOOD SPOT SAMPLE, RESULTING REACTIVE. THE SYPH RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NONREACTIVE ADVIA CENTAUR XPT SYPHILIS (SYPH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11933825 ↗
• MalfunctionJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT FOR A SAMPLE THAT WAS (B)(6) BY OTHER METHODS. THERE ARE NOT REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6631081 ↗

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