Elecsys HCG Test System 08890595190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613336169223), received between Oct 2, 2023 and Mar 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.60 MIU/ML. THE PATIENT'S CARE PROVIDER QUESTIONED THIS RESULT AS THE PATIENT IS ON ACCUTANE, AND IT IS REQUIRED THAT THEY DO NOT GET PREGNANT, AS THIS WOULD BE HIGH-RISK. THE SAME SAMPLE WAS REPEATED ON THE SAME ANALYZER AND ANOTHER COBAS E801 ANALYZER, AND THE RESULTS WERE <1 MIU/ML WITH A DATA FLAG. ON (B)(6) 2026, THE SAME SAMPLE WAS REPEATED ON THE SAME ANALYZER AND ANOTHER COBAS E801 ANALYZER, AND THE RESULTS WERE <1 MIU/ML WITH A DATA FLAG. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660843 ↗
• MalfunctionAug 18, 2025High Test Results; Output Problem; Non Reproducible Results; High Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL HCG RESULT WAS 216 MIU/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 12.4 MIU/ML. FOR SAMPLE 2, THE INITIAL HCG RESULT WAS 28.3 MIU/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 2.14 MIU/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22832704 ↗
• MalfunctionApr 29, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 194 MIU/ML. THE REPEAT RESULT WAS 14 MIU/ML. THE PATIENT WENT TO ANOTHER LABORATORY WHERE THE RESULT FROM AN UNKNOWN METHOD WAS 33 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925598 ↗
• MalfunctionApr 23, 2025Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG STAT (HCG STAT) RESULTS FROM THREE SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE PATIENT'S RESULT WAS 30.1 MIU/ML. ON (B)(6) 2025, THE PATIENT'S RESULT WAS 27.1 MIU/ML ON (B)(6) 2025, THE PATIENT'S RESULT WAS 39.2 MIU/ML.. THE REPORTER STATED THAT THE PATIENT'S URINE PREGNANCY TESTS WERE NEGATIVE AND THE DOCTOR WAS QUESTIONING THE ANALYZER'S RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893250 ↗
• MalfunctionApr 4, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.640 IU/L. THE SAMPLE WAS REPEATED TWICE ON A DIFFERENT COBAS ANALYZER WITH RESULTS OF < 1.00 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774187 ↗
• MalfunctionApr 4, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS < 1.0 MIU/ML WITH A DATA FLAG. THE PHYSICIAN QUESTIONED THIS RESULT AS THE URINE TEST RESULT WAS POSITIVE. THE SAMPLE WAS REPEATED WITH A RESULT OF 183 MIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773261 ↗
• MalfunctionSep 20, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT PLASMA SAMPLE TESTED WITH ELECSYS HCG STAT ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 6.13 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS LOW AND REQUESTED A NEW SAMPLE TO BE DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A VALUE OF 431 MIU/ML. ON (B)(6)2024 THE ORIGINAL SAMPLE WAS RETESTED. THE REPEAT RESULTS WERE 375 MIU/ML AND 432 MIU/ML. THE RESULT OF 431 MIU/ML WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271012 ↗
• MalfunctionJun 18, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON AN UNKNOWN COBAS 8000 ANALYZER UNIT. THE SAMPLE INITIALLY RESULTED IN AN HCG VALUE OF > 10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 2235 MIU/ML. THE CUSTOMER INCORRECTLY MODIFIED THE VALUE TO 223500 MIU/ML IN THE LABORATORY INFORMATION SYSTEM. THE SAMPLE WAS REPEATED AGAIN AND THE VALUE OBTAINED AGREED WITH THE 2235 MIU/ML VALUE. NO SPECIFIC RESULTS WERE PROVIDED. THE 2235 MIU/ML VALUE WAS DEEMED CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560054 ↗
• MalfunctionMay 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 402 ANALYTICAL UNIT. THE CUSTOMER QUESTIONS THE DIFFERENCE IN THE RESULTS FROM THE HEPARIN TUBE AND THE "DRY" TUBE. OF THE DATA PROVIDED, DISCREPANT RESULTS FOR COBAS CREATININE PLUS VER.2 ASSAY (CREP2) WERE ALSO GENERATED FOR THIS PATIENT SAMPLE. THIS MEDWATCH WILL COVER HCG STAT. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CREP2 RESULTS. ALL RESULTS ARE FROM THE SAME SAMPLE. THE HCG STAT RESULTS FROM THE HEPARIN TUBE WERE 734.00 IU/L, 833.00 IU/L, AND 264.00 IU/L. THE HCG STAT RESULTS FROM THE "DRY" TUBE WERE < 1.00 IU/L WITH A DATA FLAG. THESE RESULTS ARE BELIEVED TO BE CORRECT AS THE PATIENT IS NOT PREGNANT. THE CREP2 RESULT FROM THE HEPARIN TUBE WAS 454 UMOL/L. THE CREP2 RESULT FROM THE "DRY" TUBE WAS 65.3 UMOL/L. THE HEPARIN TUBE WAS RECENTRIFUGED AND RUN IN A HITACHI CUP WITH AN HCG STAT RESULT OF 273 IU/L AND A CREP2 RESULT OF 449 UMOL/L. THE RESULTS FROM THE HEPARIN TUBE ARE IN QUESTION. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297613 ↗
• MalfunctionMay 13, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 402 ANALYTICAL UNIT. THE CUSTOMER QUESTIONS THE DIFFERENCE IN THE RESULTS FROM THE HEPARIN TUBE AND THE "DRY" TUBE. OF THE DATA PROVIDED, DISCREPANT RESULTS FOR COBAS CREATININE PLUS VER.2 ASSAY (CREP2) WERE ALSO GENERATED FOR THIS PATIENT SAMPLE. THIS MEDWATCH WILL COVER CREP2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HCG STAT RESULTS. ALL RESULTS ARE FROM THE SAME SAMPLE. THE HCG STAT RESULTS FROM THE HEPARIN TUBE WERE 734.00 IU/L, 833.00 IU/L, AND 264.00 IU/L. THE HCG STAT RESULTS FROM THE "DRY" TUBE WERE < 1.00 IU/L WITH A DATA FLAG. THESE RESULTS ARE BELIEVED TO BE CORRECT AS THE PATIENT IS NOT PREGNANT. THE CREP2 RESULT FROM THE HEPARIN TUBE WAS 454 UMOL/L. THE CREP2 RESULT FROM THE "DRY" TUBE WAS 65.3 UMOL/L. THE HEPARIN TUBE WAS RECENTRIFUGED AND RUN IN A HITACHI CUP WITH AN HCG STAT RESULT OF 273 IU/L AND A CREP2 RESULT OF 449 UMOL/L. THE RESULTS FROM THE HEPARIN TUBE ARE IN QUESTION. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297607 ↗
• MalfunctionOct 2, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED WITH ELECSYS HCG STAT ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. SAMPLE 1 (PATIENT 1) WAS TESTED ON (B)(6) 2023: INITIAL RESULT: 2.66 MIU/ML. THE PHYSICIAN QUESTIONED THIS RESULT AS IT DID NOT MATCH THE PATIENT'S MEDICAL DIAGNOSIS OF AN ECTOPIC PREGNANCY AND REQUESTED THAT THE SAMPLE BE RE-TESTED. 1ST REPEAT RESULT: >10000 MIU/ML (ORIGINAL SAMPLE RE-TESTED ON A DIFFERENT E801 ANALYZER). 2ND REPEAT RESULT: AROUND 68000 MIU/ML (TESTED ON A COMPETITOR INSTRUMENT). 3RD REPEAT RESULT ON (B)(6) 2023: 48124 MIU/ML (TESTED WITH A 100 DILUTION ON THE E801 MODULE IN QUESTION). SAMPLE 2 (PATIENT 2) WAS TESTED ON (B)(6) 2023: INITIAL RESULT: 1.68 MIU/ML. REPEAT RESULT: 10000 MIU/ML ACCOMPANIED BY A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856003 ↗