Atellica IM PRGE 10995659Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00630414599779), received between Nov 8, 2019 and Jan 12, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT: 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THE CUSTOMER TESTED THE PATIENT WITH AN ALTERNATE METHOD, AND THE PROGESTERONE RESULTS WERE LOWER AS EXPECTED. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045331 ↗
• MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THE CUSTOMER TESTED THE PATIENT WITH AN ALTERNATE METHOD, AND THE PROGESTERONE RESULTS WERE LOWER AS EXPECTED. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045280 ↗
• MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THE CUSTOMER TESTED THE PATIENT WITH AN ALTERNATE METHOD, AND THE PROGESTERONE RESULTS WERE LOWER AS EXPECTED. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045211 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000246 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000244 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000242 ↗
• MalfunctionJan 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER COMPLAINS OF DISCORDANCE/FLUCTUATIONS IN ATELLICA IM PROGESTERONE (PRGE) LOT 330 RESULTS OBTAINED ON DIFFERENT DAYS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT DURING THEIR OVULATION INDUCTION CYCLES. THE CUSTOMER BELIEVES THAT THE DATA SHOULD GRADUALLY INCREASE INSTEAD OF FLUCTUATING, AS OBSERVED WITH THIS PATIENT. THE CUSTOMER'S PRGE EMPIRICAL CUTOFF VALUE (P VALUE) IS 1.5 NG/ML. THE TEST RESULTS OF THIS CASE SHOWED THAT THE P VALUES EXCEEDED 1.5 NG/ML, INDICATING LUTEINIZATION. HOWEVER, THE B-ULTRASOUND RESULTS DEMONSTRATED NORMAL FOLLICULAR GROWTH, CONCLUDING THERE IS AN INCONSISTENCY WITH THE CLINICAL OUTCOMES. THERE ARE NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000056 ↗
• MalfunctionJul 24, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANT ELEVATED PATIENT RESULTS WITH THE ATELLICA IM PROGESTERONE (PRGE) LOT#322. THESE SAMPLES WERE TESTED WHILE QUALITY CONTROL (QC) RESULTS WERE OUTSIDE ESTABLISHED RANGES. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME ATELLICA IM ANALYZER ONCE QC RESULTS WERE WITHIN ESTABLISHED RANGES; LOWER PATIENT RESULTS WERE OBTAINED. REPEAT TESTING RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821137 ↗
• MalfunctionJul 24, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANT ELEVATED PATIENT RESULTS WITH THE ATELLICA IM PROGESTERONE (PRGE) LOT#322. THESE SAMPLES WERE TESTED WHILE QUALITY CONTROL (QC) RESULTS WERE OUTSIDE ESTABLISHED RANGES. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME ATELLICA IM ANALYZER ONCE QC RESULTS WERE WITHIN ESTABLISHED RANGES; LOWER PATIENT RESULTS WERE OBTAINED. REPEAT TESTING RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. SAMPLE DATA: PLEASE REFER TO ¿2024-00056832-1_PRGE_PATIENTS SAMPLE DATA_CALCULATIONS¿ ATTACHED FOR PATIENT SAMPLE DATA AND CALCULATIONS FOR COMPLAINT (B)(4). PLEASE REFER TO ¿2024-00056832-2_PRGE_PATIENTS SAMPLE DATA_CALCULATIONS¿ ATTACHED FOR PATIENT SAMPLE DATA AND CALCULATIONS FOR COMPLAINT (B)(4). NOTE: COMPLAINT (B)(4) ADDRESSES THE DISCORDANT OBSERVATIONS OF (B)(6) 2024. COMPLAINT (B)(4) ADDRESSES THE DISCORDANT OBSERVATIONS OF (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821060 ↗
• MalfunctionApr 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCORDANT ELEVATED ATELLICA IM PROGESTERONE RESULT FOR ONE INFERTILE FEMALE PATIENT SAMPLE, USING LOT 314. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM, WHICH GAVE A RESULT SIMILAR TO THE INITIAL RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE METHOD, WHICH GAVE LOWER RESULTS COMPARED TO THE ATELLICA IM RESULTS. THE LOWER RESULT FROM THESE REPEATS WAS REPORTED TO THE PHYSICIAN(S). FOR TROUBLESHOOTING PURPOSE ONLY, THE SAMPLE WAS ALSO REPEATED ON A ADVIA CENTAUR XP INSTRUMENT, WHICH GAVE RESULTS SIMILAR TO THE ATELLICA IM RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED PROGESTERONE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714388 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296298 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296291 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296286 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296279 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296278 ↗
• MalfunctionNov 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ATELLICA IM PROGESTERONE (PRGE) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT WAS RETESTED ON ANOTHER ATELLICA IM ANALYZER AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS ON IN VITRO FERTILIZATION (IVF) PROTOCOL. THE IVF PROTOCOL WAS POSTPONED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296266 ↗

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-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-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-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-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-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-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)