Elecsys Prolactin II 03203093190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630921546), received between Sep 7, 2018 and Oct 23, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 39 NG/ML. THE SAMPLE WAS REPEATED USING THE SIEMENS ATELLICA METHOD, AND THE RESULT WAS 24.81 NG/ML. THE MACROPROLACTIN RESULT WAS NEGATIVE. ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED, AND THE ELECSYS PROLACTIN RESULT WAS 38.7 NG/ML. THE RESULT OF 24.81 NG/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372415 ↗
• MalfunctionAug 8, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE REPORTER STATED THAT THE INITIAL AND REPEAT RESULTS FROM THE ANALYZER WERE HIGH, WHILE THE RESULTS FROM A COMPETITOR ANALYZER WERE WITHIN THE NORMAL RANGE. THE REPORTER ACKNOWLEDGED THE DIFFERENCE IN THE ANALYZER'S REFERENCE RANGES BUT STATED THAT IT WAS NOT POSSIBLE BASED ON THE POPULATION. THE REPORTER STATED THAT THEY HAVE A PROCESS TO REPEAT PATIENT SAMPLES WITH HIGH RESULTS, AND IF THE RESULTS FROM THE REPEAT ARE ALSO HIGH, MAGNETIC RESONANCE IMAGING (MRI) OR MACROPROLACTIN IS ORDERED; ONE PHYSICIAN WOULD ALSO SEND OUT THE SAMPLES OF HIS PATIENTS WITH HIGH RESULTS TO ANOTHER LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750570 ↗
• MalfunctionMay 21, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH THE ELECSYS PROLACTIN ASSAY ON A COBAS E411 DISK. THE FIRST SAMPLE INITIALLY RESULTED IN A PROLACTIN VALUE OF 49.88 NG/ML. THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY USING AN UNKNOWN METHOD ON (B)(6) 2025, RESULTING IN A PROLACTIN VALUE OF 27.3 NG/ML. THE SAMPLE WAS REPEATED ON AN I-FLASH INSTRUMENT ON (B)(6) 2025, RESULTING IN A PROLACTIN VALUE OF 56.05 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN A PROLACTIN VALUE OF 32.65 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THIS SAMPLE. THE SECOND SAMPLE RESULTED IN A PROLACTIN VALUE OF 11.23 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED ON AN I-FLASH INSTRUMENT, RESULTING IN A PROLACTIN VALUE OF 14.76 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059782 ↗
• MalfunctionNov 21, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROLACTIN ASSAY ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN A PROLACTIN VALUE OF 0.866 NG/ML. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 6.05 NG/ML, 3.50 NG/ML, AND 2.18 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749497 ↗
• MalfunctionJul 2, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 0.095 NG/ML. THE REPEATED RESULTS WERE 11.56 NG/ML AND 18.54 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655783 ↗
• MalfunctionJun 3, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH ELECSYS PROLACTIN G2 (PROLACTIN II) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO A DIFFERENT ANALYZER AT A DIFFERENT FACILITY. SAMPLE (B)(6) (PATIENT (B)(6)) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 31.7 NG/ML. REPEAT RESULT: 18.66 NG/ML (TESTED ON ANOTHER ANALYZER IN A DIFFERENT LABORATORY). SAMPLE (B)(6) (PATIENT (B)(6)) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 28.5 NG/ML. REPEAT RESULT: 13.88 NG/ML (TESTED ON ANOTHER ANALYZER IN A DIFFERENT LABORATORY). SAMPLE (B)(6) (PATIENT (B)(6) ) WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 42.36 NG/ML. REPEAT RESULT: 19.78 NG/ML (TESTED ON ANOTHER ANALYZER IN A DIFFERENT LABORATORY). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453846 ↗
• MalfunctionAug 31, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROLACTIN ASSAY (PROLACTIN) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL RESULT FROM THE E411 ANALYZER WAS 663.0 UIU/ML. THE REPEAT RESULT FROM THE MAGLUMI METHOD WAS 444 UIU/ML. ON (B)(6) 2023 THE SAMPLE WAS REPEATED BY THE ARCHITECT METHOD AND THE RESULT WAS 21.00 NG/ML (446.80 UIU/ML). THE SAMPLE WAS REPEATED AS THE RESULT FROM THE E411 ANALYZER DID NOT CORRESPOND TO THE PATIENT¿S SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661750 ↗
• MalfunctionMar 31, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROLACTIN ASSAY (PROLACTIN) ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS 1000 UIU/ML. THE CUSTOMER REPEATED THE SAMPLE USING A 1:2 DILUTION AND THE RESULT WAS 10 UIU/ML. THE CUSTOMER STATED THE RESULTS DID NOT REFLECT THE PATIENT¿S CLINICAL PICTURE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657018 ↗
• MalfunctionMar 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROLACTIN GEN. 2 ASSAY VER. 2.1 ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLE INITIALLY RESULTED IN A PROLACTIN VALUE OF 42.22 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING A CHEMILUMINESCENCE METHOD AND WHEN TESTED WITH THIS METHOD, THE PROLACTIN RESULT WAS 22.50 NG/ML. THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL (PEG) AND REPEATED WITH THE CHEMILUMINESCENCE METHOD, RESULTING IN A VALUE OF 19.92 NG/ML (89 % RECOVERY). THE E411 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759830 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS 6000 E 601 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: A LOW PROLACTIN RESULT. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S GENDER WAS FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549741 ↗
• MalfunctionJan 28, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. LOW RESULTS WERE GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENT INVOLVED 1 PATIENT WITH LOW RESULTS FOR THE ELECSYS PROLACTIN ASSAY. THE PATIENT'S AGE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280772 ↗
• MalfunctionJan 25, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS HIGH RESULT WAS GENERATED BY THE COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENTS INVOLVED A TOTAL OF ONE PATIENT WITH THE FOLLOWING: ONE ERRONEOUS RESULT FOR THE ELECSYS PROLACTIN ASSAY. THE PATIENT'S AGE REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278090 ↗
• MalfunctionSep 7, 2018High Test Results; High Test Results

  THE CUSTOMER STATES THAT THE ROCHE PLATFORM HAS CONSISTENTLY HIGHER RESULTS FOR PATIENT SAMPLES TESTED WITH THE ELECSYS PROLACTIN ASSAY WHEN COMPARED TO PROLACTIN RESULTS GENERATED FROM COMPETITOR SYSTEMS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH AN ERRONEOUS PROLACTIN RESULT. WHEN TESTED TWICE ON A COBAS 8000 E 602 MODULE, THE SAMPLE RESULTED WITH PROLACTIN VALUES OF 39.73 NG/ML AND 40.18 NG/ML. AN ERRONEOUS VALUE FROM THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN SENT TO ANOTHER LABORATORY FOR TESTING ON A BECKMAN SYSTEM. WHEN REPEATED ON THE BECKMAN SYSTEM, THE SAMPLE RESULTED WITH A PROLACTIN VALUE OF 29.8 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(4). BASED ON A REVIEW OF WORLDWIDE DATA OF QC RECOVERY FOR THE REAGENT/CALIBRATOR LOT COMBINATION USED BY THE CUSTOMER, NO REAGENT ISSUE WAS FOUND. IN CASES OF IMPLAUSIBLE HIGH PROLACTIN VALUES, PRODUCT LABELING RECOMMENDS SAMPLE PRECIPITATION BY POLYETHYLENE GLYCOL (PEG) IN ORDER TO ESTIMATE THE AMOUNT OF BIOLOGICAL ACTIVE MONOMERIC PROLACTIN. THE CUSTOMER DOES NOT USE THIS PRE-TREATMENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855232 ↗