Elecsys Prolactin IIRecalls & reported problems across all models

We found 2 models of Elecsys Prolactin II by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2018 and Jan 29, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Prolactin II problems

Elecsys Prolactin II models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Prolactin II 07027737190

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  18 reports
• Elecsys Prolactin II 03203093190

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  13 reports

Recent Elecsys Prolactin II adverse event reports

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

• MalfunctionJan 29, 2026Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS PROLACTIN II ASSAY ON A COBAS PURE E 402 ANALYTICAL UNIT. INITIAL RESULT: 60.4 NG/ML. THE CUSTOMERS SENT THE SAMPLE TO ANOTHER LABORATORY USING SIEMENS, AND THE 1ST REPEAT RESULT WAS 40.5 NG/ML. THE CUSTOMER THEN REPEATED THE SAMPLE 3 TIMES, AND THE REPEAT RESULTS WERE 60.1 NG/ML, 60 NG/ML, AND 60.8 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207525 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE PROLACTIN II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0082641 FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0082642 FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866571 ↗
• 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 ↗
• MalfunctionMay 13, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SAMPLE WHEN TESTED WITH ELECSYS PROLACTIN G2 (PRL2) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 344 UIU/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. 1ST REPEAT RESULT: 2940 UIU/ML (USING A DILUTION FACTOR OF 1:10). 2ND REPEAT RESULT: 2900 UIU/ML (USING A DILUTION FACTOR OF 1:100). 3RD REPEAT RESULT: 2900 UIU/ML (USING A DILUTION FACTOR OF 1:200). A NEW SAMPLE WAS DRAWN AND TESTED ON (B)(6) 2025, RESULTING IN A PRL2 VALUE OF 336 UIU/ML. THE CUSTOMER ALLEGED THAT THE LOWER RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010661 ↗
• MalfunctionMar 25, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN II ASSAY (PROL) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PATIENT SAMPLE 1 ON (B)(6) 2025, THE INITIAL RESULT WAS 2.00 UIU/ML WITH A DATA FLAG. ON (B)(6) -2025, THE REPEAT RESULT WAS 258 UIU/ML. PATIENT SAMPLE 2 ON (B)(6) 2025, THE INITIAL RESULT WAS 2.00 UIU/ML WITH A DATA FLAG. ON (B)(6) 2025, THE REPEAT RESULT WAS 360 UIU/ML. THE CLINIC QUESTIONED THE RESULTS PROMPTING THE PATIENT SAMPLES TO BE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688322 ↗
• 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 ↗
• MalfunctionSep 17, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROLACTIN II RESULTS FOR 1 PATIENT ON 2 COBAS 8000 E 801 MODULES. ON (B)(6) 2024 THE PATIENT'S ELECSYS PROLACTIN II RESULTS WERE 30.50 NG/ML AND 39.9 NG/ML ON AN E 801 MODULE (ANALYZER A). ON (B)(6) 2024 THE INITIAL RESULT WAS 73.40 NG/ML ON ANALYZER A. THE REPEATED RESULT WAS 68.0 NG/ML ON A SECOND E 801 MODULE (ANALYZER B). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS 39.8 NG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT BUT THE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2024 THE SAME SAMPLE WAS REPEATED ON ANALYZER A AND THE RESULT WAS 73.7 NG/ML. THE SAMPLE WAS REPEATED AS THE CUSTOMER WAS AWARE OF THE PATIENT'S CLINICAL HISTORY. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DOES NOT PLAN ON SENDING A CORRECTED REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237044 ↗
• 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 10, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN II ASSAY (PROL) RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER PERFORMED A COMPARISON TEST OVER THE ASSAY'S ENTIRE MEASUREMENT RANGE. THE ALIQUOTED PATIENT SAMPLES WERE SENT TO ANOTHER LABORATORY THAT USES THE SIEMENS IMMULITE ANALYZER (CHEMILUMINESCENCE LABORATORY METHOD). PLEASE REFER TO THE ATTACHMENT PT-0069285 FOR THE TABLE CONTAINING 19 PATIENT SAMPLES WITH QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497257 ↗
• 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 ↗
• MalfunctionMay 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS PROLACTIN II ASSAY (PROL) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE E 402 ANALYTICAL UNIT. ON (B)(6) 2024, THE RESULT OF THE INITIAL SAMPLE FROM THE ANALYZER WAS 736.00 MIU/L WITH A DATA FLAG. THE PHYSICIAN DID NOT AGREE WITH THE RESULT AND REQUESTED A RERUN IN ANOTHER LABORATORY. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS REPORTEDLY NORMAL. ON (B)(6) 2024, THE RESULT OF A NEW SAMPLE WAS 210.00 MIU/L. THIS RESULT WAS CONSIDERED NORMAL AND WAS WITHIN THE LABORATORY'S REFERENCE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297627 ↗
• MalfunctionApr 12, 2024Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PROLACTIN II ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE ROCHE ASSAY DID NOT AGREE WITH THE PATIENT'S CLINICAL CONDITION. THE SAMPLE WAS TESTED ON THE E 801 ANALYZER, RESULTING IN A PROLACTIN VALUE OF 1031 UIU/ML (REFERENCE RANGE = 86 - 324 UIU/ML). THE PATIENT'S MAGNETIC RESONANCE IMAGING SHOWED RELATIVE ATROPHY OF THE PITUITARY GLAND. THE CLINICIAN DIAGNOSED THE PATIENT WITH PITUITARY ADENOMA AND PRESCRIBED BROMOCRIPTINE. THE PATIENT DID NOT TAKE THE BROMOCRIPTINE MEDICATION. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT IN A SECOND HOSPITAL AND TESTED ON A COMPETITOR SYSTEM LATER ON (B)(6) 2024. THIS SAMPLE RESULTED IN A PROLACTIN VALUE OF 7.68 NG/ML (REFERENCE RANGE = 2.1 - 17.7 NG/ML) WHEN TESTED ON THE COMPETITOR SYSTEM. THE DOCTOR AT THIS HOSPITAL DIAGNOSED THE PATIENT AS NOT HAVING A PITUITARY TUMOR. THE PATIENT THEN COMPLAINED THAT THE CUSTOMER SITE MISDIAGNOSED THE PATIENT. THE COMPLAINED SAMPLE WAS THEN SENT TO A DIFFERENT SITE FOR EXAMINATION WITH THE SAME COMPETITOR SYSTEM. THE PROLACTIN RESULT THAT WAS MEASURED ON THE COMPETITOR SYSTEM WAS 33.54 NG/ML (RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096989 ↗
• MalfunctionNov 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Unclear Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Unclear Information

  WE RECEIVED AN ALLEGATION ABOUT DISPROPORTIONAL RESULTS NOT MATCHING THE PATIENTS' CLINICAL PICTURES FOR AN UNSPECIFIED NUMBER OF PATIENTS WHEN TESTED WITH ELECSYS PROLACTIN G2 (PRL2) ASSAY ON AN E801 IMMUNOASSAY ANALYZER COMPARED TO A COMPETITOR'S (SIEMENS) PLATFORM (ATELLICA IM) USING SANDWICH IMMUNOASSAY. THE CUSTOMER ALLEGED THAT THE PATIENTS' RESULTS ARE CONSISTENTLY AROUND 50% HIGHER THAN THE CORRESPONDING SIEMENS VALUES. NO PATIENTS' RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170498 ↗

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