Atellica IM PRGE 10995660Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414599786), received between Aug 20, 2020 and Feb 9, 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.

• MalfunctionFeb 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY ELEVATED ATELLICA IM PROGESTERONE (PRGE) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. DISCORDANT ELEVATED PROGESTERONE RESULTS WERE OBSERVED FOR A 42-YEAR-OLD FEMALE PATIENT. AN INITIAL ELEVATED PRGE RESULT WAS OBTAINED AND QUESTIONED BY THE PHYSICIAN. A NEW SAMPLE WAS DRAWN AND TESTED AT ANOTHER LABORATORY (USING AN ALTERNATE TEST METHOD), AND A MUCH LOWER RESULT WAS RETURNED. THIS LOWER RESULT WAS CONSIDERED TO BE IN AGREEMENT WITH OTHER CLINICAL INDICATIONS. LATER REPEAT TESTING REPRODUCED THE INITIAL OBSERVATIONS (REPORTED SEPARATELY). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679534 ↗
• MalfunctionFeb 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY ELEVATED ATELLICA IM PROGESTERONE (PRGE) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND ALTERNATE-METHOD TESTING. DISCORDANT ELEVATED PROGESTERONE RESULTS WERE OBSERVED FOR A 42-YEAR-OLD FEMALE PATIENT. AN INITIAL DISCORDANT, ELEVATED PRGE RESULT WAS OBSERVED WHICH CONFLICTED WITH ALTERNATE-METHOD TESTING (REPORTED SEPARATELY). LATER REPEAT TESTING REPRODUCED THE INITIAL OBSERVATIONS (DISCORDANT PRGE RESULT ADDRESSED IN THIS REPORT). A NEW SAMPLE WAS DRAWN AND TESTED AT ANOTHER LABORATORY (USING AN ALTERNATE TEST METHOD), AND A MUCH LOWER RESULT WAS RETURNED. THIS LOWER RESULT WAS CONSIDERED TO BE IN AGREEMENT WITH OTHER CLINICAL INDICATIONS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679522 ↗
• MalfunctionAug 20, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ATELLICA IM 1300 PROGESTERONE (PRGE) RESULTS WHEN COMPARED TO THE IMMULITE 2000 PROGESTERONE ASSAY AND AN ALTERNATE METHOD. BOTH THE ATELLICA IM 1300 PRGE AND IMMULITE 2000 PROGESTERONE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM 1300 PRGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10432294 ↗

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-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-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-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-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-1230-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
• Z-1229-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
• Z-1231-2015 · Jan 27, 2015 · Terminated
  ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
• Z-0164-2015 · Sep 26, 2014 · Terminated
  Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)