Elecsys DHEA-S 07027192190Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04015630940387), received between Oct 31, 2022 and Jan 28, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS >1000 G/DL. THE REPEAT RESULT WAS >1000 G/DL. THE SAMPLE WAS DILUTED 1:2, AND THE RESULT WAS 1028 G/DL. THE SAMPLE WAS DILUTED 1:4, AND THE RESULT WAS 973 G/DL. THE SAMPLE WAS REPEATED ON THE ABBOTT TEST, AND THE RESULT WAS 479.9 G/DL. THE PATIENT¿S CONCURRENT LC-MS (MASS SPECTROMETRY) RESULT WAS 3.14 G/ML. NO ERRONEOUS RESULTS WERE RELEASED. THE TEST WAS REPEATED AS THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE CUSTOMER SUSPECTS INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199418 ↗
• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S ON A COBAS E 801 ANALYTICAL UNIT. 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 24183973 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Output Problem

  THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1000 G/DL WITH A DATA FLAG. THE REPEAT USING A 1:5 DILUTION WAS 113 G/DL; THE CALCULATED RESULT WAS 565 G/DL. THE MEASURING RANGE OF THE ASSAY IS 0.2 ¿ 1000 G/DL. THE CUSTOMER QUESTIONS WHY THE SAMPLE WOULD REQUIRE DILUTION, AS THE RESULT OF 565 G/DL WAS WITHIN THE MEASURING RANGE OF THE ASSAY. THE CUSTOMER SUSPECTS AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865711 ↗
• MalfunctionNov 24, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS DHEA-S ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 630 UG/DL. THE QC WENT OUT OF RANGE, PROMPTING THE REPEAT OF THE SAMPLES. REPEAT RESULT: 417 UG/DL (IT IS UNCLEAR IF THIS RESULT WAS FROM THE SAME OR A DIFFERENT E 801). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631125 ↗
• MalfunctionJul 15, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS 8000 E 801 MODULE. THE RESULT FROM THE E801 MODULE WAS > 1000 UG/DL. THE SAMPLE WAS REPEATED "SEVERAL" TIMES AND THE RESULTS WERE REPRODUCED. THE SAMPLE WAS TESTED BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) AND THE RESULT WAS 93.27 UG/DL. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505971 ↗
• MalfunctionJul 8, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1000 MCG/DL, AND THE REPEAT RESULT FROM AN E 402 ANALYZER WAS 271 MCG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE PROVIDER AND REPEATED. THERE WAS NO CORRECTED RESULT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435553 ↗
• MalfunctionApr 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 407.0 UG/DL, AND THE REPEAT RESULT WAS 221 UG/DL. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED THAT IT WAS VERY HIGH FOR THE PATIENT'S AGE, AND IT WAS NOT RELEASED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772689 ↗
• MalfunctionNov 12, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) METHOD. THE INITIAL RESULT WAS >1000 UG/DL. THE SAMPLE WAS REPEATED "SEVERAL" TIMES AND THE RESULTS REMAINED >1000 UG/DL. THE HIGH RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. DUE TO THE HIGH RESULTS, REPEAT TESTING BY LC-MS WAS REQUESTED. THE RESULT FROM THE LC-MS METHOD WAS 382.54 UG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668217 ↗
• MalfunctionJul 22, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. PATIENT 01: THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 G/DL. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN COULTER DXI 800 AND THE RESULT WAS 710 G/DL. PATIENT 02: THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 G/DL. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE BECKMAN COULTER DXI 800 AND THE RESULT WAS 947.1 G/DL. THE SAMPLE WAS RUN BY LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS) METHOD AND THE DHEA-S RESULT WAS 517.97 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793989 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 10.000 UG/DL. THE SAMPLE WAS REPEATED WITH 1:3 DILUTION AND THE RESULT WAS 4.92 UG/DL. THE SAMPLE WAS REPEATED WITH NO DILUTION AND THE RESULT WAS > 10.000 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342442 ↗
• MalfunctionMay 10, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE INITIAL RESULT FROM THE E801 ANALYZER WAS > 1000 UG/DL. THE SAMPLE WAS SENT TO TWO EXTERNAL LABORATORIES USING THE SAME COMPETITOR METHOD AND THE RESULTS WERE APPROXIMATELY 230 UG/DL. THE REPEAT RESULT ON THE E801 ANALYZER WAS > 1000 UG/DL. ON 25-APR-2024 THE SAMPLE WAS REPEATED ON THE E801 ANALYZER AND THE RESULT WAS > 1000 UG/DL WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19289035 ↗
• MalfunctionOct 31, 2022Incorrect Measurement; High Test Results; Low Test Results; Incorrect Measurement; High Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PTH IMMUNOASSAY AND ELECSYS DHEA-S ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD A QUESTIONABLE PTH VALUE WHEN TESTED ON A SECOND E 801 ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE DHEA-S ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PTH ASSAY. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF < 1.5 PG/ML WITH A DATA FLAG WHEN TESTED ON THE FIRST E 801 ANALYZER. THE SAMPLE WAS TESTED AGAIN ON A SECOND E 801 ANALYZER, RESULTING IN THE SAME VALUE. THE SAMPLE WAS FROZEN AND RE-TESTED APPROXIMATELY 1 WEEK LATER ON AN ABBOTT ALINITY ANALYZER, RESULTING IN A PTH VALUE OF 44.1 PG/ML. THE SAMPLE INITIALLY RESULTED IN A DHEA-S VALUE OF > 1000 UG/DL WITH A DATA FLAG WHEN TESTED ON THE FIRST E 801 ANALYZER. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON THE FIRST E 801 ANALYZER, RESULTING IN A VALUE OF APPROXIMATELY 1100 UG/DL. THE SAMPLE WAS FROZEN AND RE-TESTED APPROXIMATELY 1 WEEK LATER ON AN ABBOTT ALINITY ANALYZER, RESULTING IN A DHEA-S VALUE OF 211.4 UG/DL. THE RESULTS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703493 ↗