Skip to content

Elecsys Testosterone II 08946370190Recalls & reported problems

Roche Diagnostics GmbH · Testosterone G2 Elecsys E2G 300 V2 · Class 1

Adverse event reports
19
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613336170571), received between May 2, 2023 and Apr 14, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “High Test Results” (16 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 1 reportsDec 2025: 3 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • High Test Results16
  • Incorrect Measurement6
  • Non Reproducible Results5
  • Incorrect, Inadequate or Imprecise Result or Readings4
  • Low Test Results3
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions19

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

    WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II), ELECSYS ESTRADIOL III (ESTRADIOL III), AND ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE SIEMENS METHOD AND LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS). THIS MEDWATCH WILL COVER TESTOSTERONE II. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE PROLACTIN II RESULTS. THE TESTOSTERONE II RESULT FROM THE E801 ANALYZER WAS 52.0 NMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 25 NMOL/L. THE LC-MS RESULT WAS 17.7 NMOL/L. THE ESTRADIOL III RESULT FROM THE E801 ANALYZER WAS 474 PMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.16 PMOL/L. THE PROLACTIN II RESULT FROM THE E801 ANALYZER WAS 265 MU/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.17 IU/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24877022 ↗
  • MalfunctionMar 17, 2026Incorrect, 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 TESTOSTERONE II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TESTOSTERONE VALUE OF 46 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF 40.5 NMOL/L. THE SAMPLE WAS TESTED ON A COMPETITOR SYSTEM (ABBOTT ALINITY) AND IT RESULTED IN A TESTOSTERONE VALUE OF 10.3 NMOL/L. THE SAMPLE WAS ALSO TESTED USING THE LC-MS/MS METHOD, RESULTING IN A TESTOSTERONE VALUE OF 12.3 NMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24616337 ↗
  • MalfunctionJan 26, 2026High Test Results

    1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TESTOSTERONE II ON A COBAS E 801 ANALYTICAL UNIT WHEN COMPARED TO ABBOTT. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: FEMALE, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24184135 ↗
  • 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 TESTOSTERONE 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 (B)(6) FOR INFORMATION RELATED TO THE SHBG 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 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 PROLACTIN II 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 THE ANT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23866556 ↗
  • MalfunctionDec 15, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <2.5 NMOL/L. THE PHYSICIAN QUESTIONED THE RESULT, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULT WAS 6.24 NMOL/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23808625 ↗
  • MalfunctionDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 801 MODULE. INITIAL RESULT: 30.4 NMOL/L. ON (B)(6) 2025: REPEAT RESULT: 19.12 NMOL/L (TESTED USING BECKMAN).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23686682 ↗
  • MalfunctionNov 11, 2025High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY AND ELECSYS ESTRADIOL III RESULTS FOR ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ELECSYS TESTOSTERONE II ASSAY. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS ESTRADIOL III ASSAY. THE PATIENT HAD BEEN CONTINUOUSLY MONITORED FOR OVER THREE MONTHS AND HAD CONSISTENTLY ELEVATED RESULTS FROM THREE E 801 ANALYZERS. THE PATIENT WENT TO ANOTHER HOSPITAL FOR TESTING AND REPORTED TO THE CLINICIAN THAT THE RESULTS FROM A SIEMENS ANALYZER WERE NORMAL. ON (B)(6) 2025, THE PATIENT HAD NEW SAMPLES COLLECTED. THE TESTOSTERONE RESULT FROM THE ANALYZER WAS 3.39 NMOL/L. THE TESTOSTERONE RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 1.401 NMOL/L. THE ESTRADIOL RESULT FROM THE ANALYZER WAS 2444 PMOL/L. THE ESTRADIOL RESULT FROM A MASS SPECTROMETRY ANALYZER WAS 896 PMOL/L. THE MASS SPECTROMETRY RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE REPORTER SUSPECTS AN INTERFERENT IN THE PATIENT'S SAMPLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23524601 ↗
  • MalfunctionOct 22, 2025High Test Results; High Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.76 NMOL/L. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS 0.45 NMOL/L. THE INITIAL RESULT WAS INCONSISTENT WITH THE PATIENT'S CLINICAL PICTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23359036 ↗
  • MalfunctionOct 15, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.05 NG/ML. THE RESULT WAS QUESTIONED BECAUSE IT SEEMED UNEXPECTEDLY HIGH. THE SAMPLE WAS TESTED USING ANOTHER METHOD (SIEMENS), AND THE REPEATED RESULT WAS 0.561 NG/ML. THE CLINICIAN BELIEVES THE REPEATED RESULT IS MORE ACCURATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23294200 ↗
  • MalfunctionAug 12, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect Measurement; 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 TESTOSTERONE II ASSAY ON A COBAS E 801 MODULE. THE PATIENT'S SAMPLE RESULTED IN A TESTOSTERONE VALUE OF > 52.0 NMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING AS > 52.0 NMOL/L. THE CLINICIAN SUSPECTED THAT THE TESTOSTERONE RESULTS WERE INCONSISTENT WITH PREVIOUS VALUES. THE SAMPLE WAS REPEATED TWICE USING THE BECKMAN PLATFORM, RESULTING IN TESTOSTERONE VALUES OF 5.97 NG/ML (21.9 NMOL/L) AND 20.7 NMOL/L (REFERENCE RANGE = 6.07 TO 27.1 NMOL/L).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22782531 ↗
  • MalfunctionJul 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TESTOSTERONE G2 (TESTOSTERONE II) ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE WAS TESTED ON SIEMENS, AND THE RESULT WAS 897 NG/DL. THE ORIGINAL SAMPLE WAS TESTED ON AN E801, AND THE RESULT WAS 1500 NG/DL (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED TWICE ON E801, AND THE REPEAT RESULTS WERE BOTH 1500 NG/DL (ACCOMPANIED BY DATA FLAGS). ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED ON SIEMENS, AND THE REPEAT RESULT WAS 897 NG/DL. THE SAMPLE WAS THEN REPEATED ON SIEMENS USING A DIFFERENT MODULE, AND THE REPEAT RESULT WAS 816 NG/DL. NO QUESTIONABLE RESULTS WERE REPORTED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22555006 ↗
  • MalfunctionMay 13, 2025High Test Results; High Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY AND ELECSYS TESTOSTERONE II ASSAY RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS 6000 CORE UNIT 150 (CN VERS.) AND COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TESTOSTERONE II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ESTRADIOL III ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE COBAS E 601 ANALYZER RESULTS WERE INCONSISTENT WITH THE PATIENTS' CLINICAL STATUSES. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22008568 ↗
  • MalfunctionJan 27, 2025Low 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 TESTOSTERONE II ASSAY ON A COBAS E 801 MODULE. THE SAMPLE WAS INITIALLY MEASURED IN A CUP AND GENERATED NO VALUE OTHER THAN A FLAG INDICATING THERE WAS A SAMPLE BUBBLE. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 0.231 NMOL/L. THE VALUE WAS REPORTED TO THE DOCTOR AND THE DOCTOR COMPLAINED ABOUT THE LOW VALUE. THE SAMPLE WAS REPEATED IN THE SAME CUP ON (B)(6) 2024 AND IT RESULTED IN A VALUE OF 26.3 NMOL/L. THE 26.3 NMOL/L VALUE FIT WITH THE MEDICAL EXPECTATIONS FOR THE AFFECTED PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21240662 ↗
  • MalfunctionJan 9, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II) ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER HAS BEEN MONITORING THE PATIENT¿S TESTOSTERONE II RESULTS FOR 1 MONTH. THE PATIENT HAD BEEN TAKING RECTAL CANNABIGEROL (CBG) DURING THIS 1 MONTH PERIOD; THE LAST DOSE WAS ON (B)(6) 2024. ON (B)(6) 2024 THE RESULT WAS 30.7 NMOL/L. ON (B)(6) 2024 THE RESULT WAS 19.4 NMOL/L. ON (B)(6) 2024 THE RESULT WAS 30.6 NMOL/L. ON (B)(6) 2024 THE RESULT WAS 16.3 NMOL/L. THE CUSTOMER SUSPECTS AN INTERFERENCE WITH THE CBG THERAPY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21114922 ↗
  • MalfunctionMar 6, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TESTOSTERONE G2 (TESTOSTERONE II) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO THE LIQUID CHROMATOGRAPHY MASS SPECTROMETRY (LCMS) METHOD. THE INITIAL RESULT WAS REPORTEDLY 1192 NG/DL. ON (B)(6) 2023 A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS REPORTEDLY 899 NG/DL. ON (B)(6) 2023 A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS REPORTEDLY 854 NG/DL. THE PROVIDER QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S HISTORY. ON (B)(6) 2023 A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED WITH LCMS METHOD. THE RESULT WAS REPORTEDLY APPROXIMATELY 200 NG/DL. THE EXACT RESULT WAS NOT PROVIDED. THE RESULT TESTED WITH LCMS METHOD WAS DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18847459 ↗
  • MalfunctionDec 15, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS OF 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS TESTOSTERONE G2 (TESTOSTERONE II) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO LIQUID CHROMATOGRAPHY MASS SPECTROMETRY (LC/MS) METHODOLOGY. INITIAL RESULT: 4.33 NMOL/L. 1ST REPEAT RESULT: 4.38 NMOL/L (REPEATED ON E801). 2ND REPEAT RESULT: 0.3 NMOL/L (TESTED WITH LC/MS - REFERRAL LABORATORY). 3RD REPEAT RESULT: 0.39 NMOL/L (REPEATED WITH LC/MS). 4TH REPEAT RESULT: 1.01 NMOL/L (TESTED ON BECKMAN COULTER).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18336075 ↗
  • MalfunctionOct 30, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN A TESTOSTERONE VALUE OF 14.8 NMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE PATIENT WAS THEN SENT TO ANOTHER HOSPITAL WHERE ANOTHER SAMPLE WAS COLLECTED AND THIS SAMPLE RESULTED IN A LOW TESTOSTERONE VALUE. THE COMPLAINED SAMPLE WAS THEN REPEATED USING A COMPETITOR METHOD, RESULTING IN A TESTOSTERONE VALUE OF 0.94 NMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18032047 ↗
  • MalfunctionMay 12, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TESTOSTERONE II RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023, THE INITIAL RESULT USING THE PRIMARY TUBE WAS 1500 NG/DL WITH A DATA FLAG. THE REPORTER THEN DILUTED THE PATIENT SAMPLE TO 1:5. IT IS NOT CLEAR IF THE FINAL RESULT OF THIS DILUTION IS 435 NG/DL. OR 500 NG/DL. ON (B)(6) 2023, IT IS NOT CLEAR IF THE RESULT OF 87.8 NG/DL WAS A REPEAT RESULT. ANOTHER REPEAT RESULT USING THE PRIMARY TUBE WAS 587 NG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16919273 ↗
  • MalfunctionMay 2, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

    THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS TESTOSTERONE II ON THE CUSTOMER'S COBAS E 801 MODULE (SERIAL NUMBER (B)(6) ) AND UP TO THREE E 801 ANALYZERS AT A SECOND SITE (SERIAL NUMBERS (B)(6) ). THE REPORTER STATED THE ISSUE OCCURS RARELY, BUT HAS OCCURRED OFTEN ENOUGH TO QUESTION WHETHER THE AFFECTED SAMPLES MAY CONTAIN AN INTERFERING SUBSTANCE. SAMPLES ARE COLLECTED FROM PATIENTS AND ALIQUOTS OF EACH SAMPLE ARE TESTED WITH THE SAME ROCHE TESTOSTERONE ASSAY AT THE CUSTOMER SITE AND AT THE SECOND SITE. THE REPORTER STATED FOR EXAMPLE, A PATIENT SAMPLE ALIQUOT TESTED AT THE CUSTOMER SITE WILL RESULT IN A TESTOSTERONE VALUE OF 10 NG/ML, AND THE ALIQUOT SENT TO THE SECOND SITE WILL RESULT IN A VALUE OF 100 NG/ML. WHEN THE ALIQUOT FROM THE SECOND SITE IS THEN TESTED AT THE CUSTOMER SITE, IT RESULTS IN A VALUE OF 100 NG/ML AND WHEN THE CUSTOMER ALIQUOT IS SENT TO THE SECOND SITE, IT RESULTS IN A VALUE OF 10 NG/ML. THE CUSTOMER PROVIDED SAMPLE DATA FOR TWENTY-THREE PATIENTS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLES WERE TESTED ON THE CUSTOMER'S E 801 ANALYZER AND THEN REPEATED AT THE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16854926 ↗

Other RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE devices

All RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.