Elecsys Prolactin II 07027737190Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04015630940097), received between Aug 27, 2018 and Jan 29, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “High Test Results” (13 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 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 20, 2023Incorrect 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 E411 RACK. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTICED THE DISCREPANT RESULTS UPON PERFORMING A COMPARISON BETWEEN THE ANALYZER AND A SIEMENS ANALYZER. THE REPORTER USED PATIENT SAMPLES PROCESSED FROM (B)(6) 2023 TO (B)(6) 2023. THE REPORTER DID NOT PERFORM THE RECOMMENDED PATIENT SAMPLE PRETREATMENT USING THE POLYETHYLENE GLYCOL (PEG) PRECIPITATION TEST. THE REPORTER WAS ADVISED TO PERFORM THIS PROCEDURE. PLEASE REFER TO THE ATTACHMENT (B)(6 IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED EXAMPLES OF QUESTIONABLE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170169 ↗
• MalfunctionMay 3, 2022Low Test Results; Insufficient Device Problem Information; Low Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN II RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE WITH A SERIAL NUMBER (B)(4). THE CUSTOMER CONFIRMED THE QC RESULTS WERE ACCEPTABLE. THE PATIENT'S INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED RESULT DUE TO THE RESULT NOT MATCHING THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER PERFORMED DILUTION TESTING WITH THE PATIENT'S SAMPLE ON THE SAME E 801 MODULE. IT WAS REPORTED THE PROLACTIN RESULT "GRADUALLY BECOMES LARGER THE MORE IT IS DILUTED." THE PATIENT'S INITIAL PROLACTIN RESULT WAS 14.3 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:2 DILUTION WAS 14.4 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:4 DILUTION WAS 14.7 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:8 DILUTION WAS 13.8 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:10 DILUTION WAS 15.2 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:40 DILUTION WAS 20.0 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:80 DILUTION WAS 25 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:100 DILUTION WAS 110 NG/ML. THE PATIENT'S PROLACTIN RESULT WITH A 1:10000 DILUTION WAS 900 NG/ML. THE CUSTOMER "PREDICTS THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268587 ↗
• MalfunctionApr 18, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PROLACTIN G2 ELECSYS RESULTS FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 40.9 MG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 41.6 MG/ML. ON (B)(6) 2022, THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CLIA METHOD AND THE RESULT WAS 28.26 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136476 ↗
• MalfunctionDec 14, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S SAMPLE WAS INITIALLY TESTED ON AN ARCHITECT ANALYZER AT A DIFFERENT LABORATORY. THE ARCHITECT'S RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER SENT THE PATIENT'S SAMPLE FOR AN INVESTIGATION AND WAS TESTED ON AN E 801 MODULE. ON (B)(6) 2021, THE PATIENT'S PROLACTIN RESULT ON THE ARCHITECT ANALYZER WAS 95.27 NG/ML. ON (B)(6) 2021, THE PATIENT'S PROLACTIN RESULTS ON THE E 801 MODULE WERE 39.7 NG/ML AND 40 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001907 ↗
• MalfunctionNov 23, 2021High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS PROLACTIN ASSAY (PROLACTIN) ON A COBAS E801 MODULE. ON (B)(6) 2021 THE INITIAL RESULT FROM THE E801 MODULE WAS 3045 MIU/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE FROM (B)(6) 2021 WAS TESTED BY THE SIEMENS METHOD WITH A RESULT OF 2040.14 MIU/L AND BY THE BECKMAN METHOD WITH A RESULT OF 1735.43 MIU/L. THE CUSTOMER TREATED THE SAMPLE FROM (B)(6) 2021 WITH POLYETHYLENE GLYCOL (PEG) AND THE RESULT FROM THE E801 MODULE WAS 2334 MIU/L. ON (B)(6) 2021 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE E801 MODULE WAS 232 MIU/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE FROM (B)(6) 2021 WAS TESTED BY THE SIEMENS METHOD WITH A RESULT OF 144.22 MIU/L AND BY THE BECKMAN METHOD WITH A RESULT OF 150.3 MIU/L. THE SAMPLE FROM (B)(6) 2021 WAS NOT TREATED AND TESTED USING PEG. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862090 ↗
• MalfunctionJul 29, 2021High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED A RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E801 MODULE. THE INITIAL RESULT FROM THE CUSTOMER¿S E801 MODULE WAS 44 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED ADDITIONAL TESTING. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE THE RESULT FROM AN E801 MODULE USED AT THE INVESTIGATION SITE WAS 57.8 NG/ML. THE E801 MODULE SERIAL NUMBER USED AT THE CUSTOMER SITE IS NOT KNOWN. THE E801 MODULE USED AT THE INVESTIGATION SITE WAS (B)(4). THE PROLACTIN II REAGENT LOT USED AT THE INVESTIGATION SITE WAS 482648 WITH AN EXPIRATION DATE OF NOV-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12244543 ↗
• MalfunctionNov 12, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO AN ADVIA CENTAURO. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS FT3 III, ELECSYS PROLACTIN ASSAY, ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS TESTOSTERONE II ASSAY, AND ELECSYS ESTRADIOL III ASSAY. THE CUSTOMER SUSPECT THERE IS AN INTERFERENCE AFFECTING THE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE PROLACTIN ASSAY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6). THE DISCREPANT RESULTS ARE HIGHLIGHTED. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059171 ↗
• MalfunctionAug 29, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FROM 2 SEPARATE SAMPLES FROM 1 PATIENT THAT WERE NOT MATCHING THE PATIENT'S CLINICAL PICTURE. PLEASE REFER TO THE ATTACHMENT TO THIS MEDWATCH FOR PATIENT DATA. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS NOT PROVIDED. THE PROLACTIN REAGENT LOT USED AT THE INVESTIGATION SITE WAS 293123 WITH AN EXPIRATION DATE OF 31-MAY-2019. THE COBAS E801 USED AT THE INVESTIGATION SITE WAS SERIAL NUMBER (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7826025 ↗
• MalfunctionAug 27, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PROLACTIN ASSAY ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER ROUTINELY TESTS SAMPLES FOR PROLACTIN ON THEIR TOSOH AIA-2000 ANALYZER. THE SAMPLE WAS INITIALLY TESTED ON THE AIA-2000 ANALYZER, RESULTING WITH A PROLACTIN VALUE OF 255.8 NG/ML. THE PHYSICIAN QUESTIONED THE RESULT AND ASKED FOR THE SAMPLE TO BE REPEATED ON THE E 801 ANALYZER. THE REPEAT PROLACTIN RESULT FROM THE E 801 ANALYZER WAS 343.9 NG/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 801 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818081 ↗