ADVIA Centaur® PRGE 10310305Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414204147), received between Dec 3, 2020 and May 1, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 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.

• MalfunctionMay 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF A DISCORDANT ELEVATED ADVIA CENTAUR CP PROGESTERONE (PRGE) RESULT ON A PATIENT SAMPLE VERSUS REPEAT TESTING. THE DISCORDANT ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ADVIA CENTAUR CP INSTRUMENT AND RECOVERED LOWER RESULTS. THE LOWER REPEAT RESULTS WERE CONSIDERED CORRECT, AS THE RESULTS CORRELATED BETTER WITH THIS PATIENT'S ULTRASOUND FINDINGS. A RESULT OF 0.72 NG/ML WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED PRGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220770 ↗
• MalfunctionDec 1, 2021High Test Results; High Test Results

  A DISCORDANT, ELEVATED ADVIA CENTAUR CP PROGESTERONE (PRGE) RESULT WAS OBSERVED BY THE CUSTOMER DURING A SERIES OF TESTS PERFORMED ON ONE PATIENT. A PATIENT INITIALLY PRODUCED A RESULT OF <0.5 NG/ML, WHICH TRIGGERED REPEAT TESTING ACCORDING TO LOCAL PROTOCOL. UPON REPEAT, THE SAMPLE PRODUCED A RESULT OF 4.71 NG/ML. THIS HIGHER RESULT WAS CONSIDERED DISCORDANT, AS THREE ADDITIONAL TESTS PRODUCED RESULTS WHICH AGREED WITH THE INITIAL RESULT. THE LOWER MEASUREMENT (0.50 NG/ML) WAS ACCEPTED AS CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, HIGH ADVIA CENTAUR CP PROGESTERONE (PRGE) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910418 ↗
• MalfunctionDec 3, 2020High Test Results; High Test Results

  A DISCORDANT, HIGH ADVIA CENTAUR XPT PROGESTERONE (PRGE) RESULT WAS OBTAINED BY THE CUSTOMER AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS SENT TO AN ALTERNATE REFERENCE LABORATORY, TESTED WITH AN ALTERNATE PROGESTERONE METHOD, RESULTING LOWER. THE LOWER ALTERNATE PROGESTERONE TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, HIGH ADVIA CENTAUR XPT PROGESTERONE (PRGE) RESULT, HOWEVER THE PATIENT'S FET( FROZEN EMBRYO TRANSFER) CYCLE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937615 ↗

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-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-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-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-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-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-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-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)