ADVIA Centaur® PRGE +E 10315522Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00630414454641), received between Jul 25, 2022 and Sep 16, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 reports).

11 other recalls cover devices cleared under the same FDA submission (K932955); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785818 ↗
• MalfunctionJun 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR PROGESTERONE (PRGE) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHILE USING LOT 321. AN INITIAL ELEVATED RESULT (ABOVE ASSAY MEASURING RANGE) WAS OBTAINED FOR A FEMALE PATIENT. THIS ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-TESTED AFTER MANUAL DILUTION (1:2) AND PRODUCED A MUCH LOWER RESULT. THE SAME SAMPLE WAS REPEAT-TESTED NEAT (UNDILUTED) AND A SIMILAR LOW RESULT WAS OBTAINED. THIS LOWER RESULT WAS CONSISTENT WITH CLINICAL EXPECTATION, ACCEPTED AS CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493334 ↗
• MalfunctionDec 1, 2023High Test Results; High Test Results

  ONE (1) FALSELY ELEVATED PROGESTERONE (PRGE) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED TWICE ON THE ORIGINAL INSTRUMENT AND LOWER RESULTS WERE OBTAINED. A NEW SAMPLE WAS REDRAWN FROM THE SAME PATIENT AND TESTED ON THE SAME INSTRUMENT, OBTAINED A LOWER RESULT. THE RETESTED RESULT OBTAINED FROM THE INITIAL SAMPLE WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PROGESTERONE (PRGE) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246584 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547456 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS ON ONE PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER RETESTED THE SAMPLE AGAIN ON 2 DIFFERENT DAYS USING THE ADVIA CENTAUR XP AND USING THE ALTERNATE METHOD. RESULTS WERE SIMILAR TO THE INITIAL RESULTS. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547451 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS ON ONE PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER RETESTED THE SAMPLE AGAIN ON 2 DIFFERENT DAYS USING THE ADVIA CENTAUR XP AND USING THE ALTERNATE METHOD. RESULTS WERE SIMILAR TO THE INITIAL RESULTS. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547447 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547446 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547442 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547435 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547427 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS ON ONE PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER RETESTED THE SAMPLE AGAIN ON 2 DIFFERENT DAYS USING THE ADVIA CENTAUR XP AND USING THE ALTERNATE METHOD. RESULTS WERE SIMILAR TO THE INITIAL RESULTS. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547330 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547322 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547298 ↗
• MalfunctionOct 5, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE THAT DID NOT MATCH THE CLINICAL PROFILE. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS RETESTED IN A REFERENCE LABORATORY WITH AN ALTERNATE METHOD. THE RESULT WAS LOWER AND WAS MORE IN LINE WITH PATIENT CLINICAL PROFILE. A CORRECTED REPORT WAS ISSUED. THERE IS NO REPORT THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547225 ↗
• MalfunctionJul 25, 2022High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULT ON A SERUM SAMPLE. THE ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED USING AN ALTERNATE METHOD AND THE RESULT WAS LOWER. THE CUSTOMER BELIEVES THE ELEVATED ADVIA CENTAUR XP RESULT DOES NOT MATCH THE STAGE IN THE MENSTRUAL CYCLE OF THE PATIENT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED PROGESTERONE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932955. One submission often covers many models, so check the product and lot details in each record.

• Z-1421-2017 · Jan 4, 2017 · Terminated
  IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1
• Z-1418-2017 · Jan 4, 2017 · Terminated
  ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progestero
• Z-1419-2017 · Jan 4, 2017 · Terminated
  Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progest
• Z-1420-2017 · Jan 4, 2017 · Terminated
  IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers-
• Z-1077-2016 · Feb 4, 2016 · Terminated
  Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration t
• Z-1079-2016 · Feb 4, 2016 · Terminated
  Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur Calibrator E For in vitro diagnostic use in cal
• Z-1078-2016 · Feb 4, 2016 · Terminated
  Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the
• Z-1230-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
• Z-1231-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
• Z-1229-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
• Z-0164-2015 · Sep 26, 2014 · Terminated
  Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)