Elecsys HCG Test System 08890587190Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07613336169216), received between Oct 21, 2021 and Aug 5, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (25 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139198 ↗
• MalfunctionMar 12, 2026Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG STAT RESULT FROM THE COBAS 6000 C (501) MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 62.40 MIU/ML, AND THE REPEAT RESULT WAS 5420 MIU/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED AFTER THE PATIENT HAD A DISCUSSION WITH THE DOCTOR, AND THE DOCTOR REQUESTED THE REPEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583936 ↗
• MalfunctionNov 25, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ASSAY ON A COBAS 6000 E601 MODULE. INITIAL RESULT: 13 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, PROMPTING THE REPEAT OF THE SAMPLE. REPEAT RESULT: 40.016 MIU/ML (TESTED ON A COBAS E 801 ANALYZER). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643884 ↗
• MalfunctionNov 7, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE. ON (B)(6) 2025: THE INITIAL RESULT OF THE FIRST PATIENT SAMPLE WAS <1.0 MIU/ML WITH A DATA FLAG. THE PHYSICIAN QUESTIONED THE RESULT AS THEY KNEW THE PATIENT WAS PREGNANT. THE INITIAL RESULT OF THE SECOND PATIENT SAMPLE (UNDILUTED) WAS >10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT OF THE SECOND PATIENT SAMPLE (AT 1:100 DILUTION) WAS 21697 MIU/ML OR 22000 MIU/ML. ON (B)(6) 2025: THE REPEAT RESULT OF THE FIRST PATIENT SAMPLE (UNDILUTED) WAS >10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT OF THE FIRST PATIENT SAMPLE (AT 1:100 DILUTION) WAS 21508 MIU/ML. THE REPEAT RESULT OF THE FIRST PATIENT SAMPLE (UNDILUTED) WAS >10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT OF THE FIRST PATIENT SAMPLE (AT 1:100 DILUTION) WAS 21986 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498211 ↗
• MalfunctionJul 25, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT RESULTS FOR 1 PATIENT ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 4.92 MIU/ML. THE SAMPLE WAS RETESTED ON ANOTHER MODULE, AND THE REPEATED RESULT WAS 1 MIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE PATIENT HAD A NEGATIVE URINE SCREEN RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608313 ↗
• MalfunctionJun 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT RESULTS FROM THE COBAS 8000 CORE UNIT. TWO SAMPLE TUBES WITH THE SAME SAMPLE ID WERE TESTED AND GAVE DIFFERING RESULTS. TUBE 1 HAD A RESULT OF 1822 MIU/ML AND A REPEAT RESULT OF 1808 MIU/ML TUBE 2 HAD A RESULT OF <1 MIU/ML WITH A DATA FLAG. THE RESULT OF 1822 MIU/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356958 ↗
• MalfunctionMay 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG STAT (HCG STAT) RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E411 DISK. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 9.6 MIU/ML. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS <1 MIU/ML. THE SECOND REPEAT RESULT FROM ANOTHER E 411 ANALYZER WAS 9.6 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078480 ↗
• MalfunctionMar 12, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: <1 MIU/ML. THE CLINICAL STAFF QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: >90 MIU/ML. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT RESULTS. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586419 ↗
• MalfunctionJan 3, 2025Low Test Results; Output Problem; Non Reproducible Results; Low Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG STAT (HCG STAT) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULTS WERE QUESTIONED AS THE PATIENTS WERE PREGNANT. SAMPLE 1 THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS <1.00 MIU/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS >10000 MIU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 21828 MIU/ML WITH A DATA FLAG. SAMPLE 2 THE INITIAL RESULT WAS <1.00 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS >10000 MIU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067137 ↗
• MalfunctionOct 30, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON A COBAS 6000 E 601 MODULE. THE SAMPLE INITIALLY RESULTED IN AN HCG VALUE OF 3 MIU/ML. A NURSE REQUESTED A REPEAT OF THE SAMPLE BECAUSE THE PATIENT HAD A POSITIVE HOME PREGNANCY TEST. THE SAMPLE WAS REPEATED TWICE, RESULTING IN HCG VALUES OF 119.8 MIU/ML AND 116.0 MIU/ML. THE 119.8 MIU/ML VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567456 ↗
• MalfunctionOct 25, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL HCG RESULT WAS 1.00 MIU/ML WITH FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 106.2 MIU/ML WITH FLAG. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER E411 ANALYZER AND THE RESULT WAS 103.0 MIU/ML WITH FLAG. THE RESULT WAS 103.0 MIU/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535889 ↗
• MalfunctionJun 4, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 601 MODULE. ON (B)(6) 2024 "PATIENT 2" INITIAL RESULT WAS 97 MIU/ML. ON (B)(6) 2024 THE REPEAT RESULT WAS "UNDETECTABLE." THE SPECIFIC RESULT WAS NOT PROVIDED. A 2ND SAMPLE WAS OBTAINED. THE 2ND SAMPLE WAS RUN ON AN E801 MODULE WITH A RESULT OF 1.0 MIU/ML. ON (B)(6) 2024 "PATIENT 1" INITIAL RESULT WAS 5 MIU/ML. THE REPEAT RESULT WAS "UNDETECTABLE." THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2024 ANOTHER SAMPLE TUBE WAS REPEATED AND THE RESULT WAS "UNDETECTABLE." THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460654 ↗
• MalfunctionFeb 12, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG STAT (HCG STAT) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS >10000 MIU/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 169.4 MIU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 12513 MIU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684324 ↗
• MalfunctionFeb 9, 2024Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HCG STAT VALUE OF > 10000 IU/L WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND REPEATED 3 TIMES, RESULTING IN HCG STAT VALUES OF 8900 IU/L, 8600 IU/L, AND 8800 IU/L. THE SAMPLE WAS DILUTED 1:50 AND REPEATED, RESULTING IN AN HCG STAT VALUE OF 11315 IU/L. THE SAMPLE WAS DILUTED 1:2 AND REPEATED, RESULTING IN AN HCG STAT VALUE OF 11232 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675317 ↗
• MalfunctionJan 8, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE DOCTOR QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION, WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL HCG RESULT WAS 29.11 MIU/ML. THE REPEAT RESULT WAS 22.3 MIU/ML. ON 15-DEC-2023, THE SAMPLE WAS REPEATED 5 TIMES AND THE RESULTS WERE 21.75 MIU/ML, 21.53, MIU/ML, 21.92 MIU/ML, 21.69 MIU/ML, AND 22.31 MIU/ML. THE FIRST REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464428 ↗
• MalfunctionDec 5, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON A COBAS E411 RACK. THE PATIENT WAS TESTED FOR PREGNANCY AND IS CONFIRMED TO BE PREGNANT. THE SAMPLE RESULTED IN AN HCG VALUE OF 2.47 MIU/ML. A SECOND SAMPLE FROM THE PATIENT WAS COLLECTED AT ANOTHER SITE AND TESTED WITH THE ROCHE ELECSYS HCG STAT REAGENT ON 23-OCT-2023, RESULTING IN AN HCG VALUE OF 52000 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265459 ↗
• MalfunctionNov 9, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG STAT (HCG STAT) RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS E411 RACK. ON (B)(6) 2023: SAMPLE (B)(6). THE PATIENT SAMPLE WAS SENT TO A SISTER LABORATORY THAT ALSO USES ELECSYS HCG STAT AND AN E 411 FOR CHECKING BEFORE REPORTING THE RESULT TO THE PHYSICIAN. THE INITIAL RESULT OF THE UNDILUTED SAMPLE FROM THE ANALYZER WAS >10000 MIU/ML. WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER ON AUTO DILUTION WAS 291.2 MIU/ML. THE SECOND REPEAT RESULT OF THE UNDILUTED SAMPLE FROM THE SISTER LABORATORY'S E 411 WAS >10000 MIU/ML. THE THIRD REPEAT RESULT OF A DILUTED SAMPLE FROM THE SISTER LABORATORY'S E 411 WAS 24994 MIU/ML. A RESULT OF 24995 MIU/ML FROM THE SISTER LABORATORY WAS REPORTED TO THE DOCTOR. ON (B)(6) 2023, THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND CHECKED THE SOLUTIONS. HE ALSO PERFORMED A MIXING CHECK. HE PERFORMED THE NECESSARY ADJUSTMENTS TO THE MIXER AND THE SAMPLE/REAGENT (S/R) PROBES. HE CHECKED THE S/R VOLTAGE AND NOTED THAT THE RESULTS WITH A TIP AND WITHOUT A TIP WERE INVERSE. HE THEN PERFORMED A VOLTAGE ADJUSTMENT ON THE LIQUID-LEVEL DETECTION (LLD) BOARD. CALIBRATIONS AND QCS WERE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099829 ↗
• MalfunctionOct 20, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS <0.500 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED AS THE PATIENT COMPLAINED. THE REPEAT RESULT WAS 326.3 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977904 ↗
• MalfunctionAug 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL HCG RESULT WAS 3.00 MIU/ML WITH FLAG. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 19.86 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476040 ↗
• MalfunctionJul 21, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG STAT (HCG STAT) ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS < 1 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PHYSICIAN AS THE PATIENT WAS PREGNANT. THE REPEAT RESULT WAS 16,452 MIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372063 ↗
• MalfunctionJul 20, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE HCG STAT ELECSYS RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 64.53 MIU/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 42728 MIU/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED TO THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366471 ↗
• MalfunctionJun 12, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HCG STAT ELECSYS RESULT FROM COBAS E411 RACK ANALYZER SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS 232 MIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY THE NURSE. THE REPEAT RESULT ON THE SAME ANALYZER WAS 125.1 MIU/ML AND WAS BELIEVED TO BE THE CORRECT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108328 ↗
• MalfunctionFeb 6, 2023High Test Results; Non Reproducible Results; High 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 6000 E 601 MODULE. THE INITIAL RESULT WAS 1609 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED REPEAT TESTING AS THE RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE REPEAT RESULT WAS 1.00 MIU/ML WITH A DATA FLAG. THIS RESULT WAS BELIEVED TO BE CORRECT. THE HCG STAT REAGENT LOT NUMBER WAS 62829300 WITH AN EXPIRATION DATE OF 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306693 ↗
• MalfunctionFeb 2, 2023Imprecision; Low Test Results; Non Reproducible Results; Imprecision; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS HCG STAT ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT 1: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN AN HCG STAT VALUE OF 9536 MIU/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY USING THE ABBOTT ARCHITECT METHOD (BHCG QUANTITATIVE) RESULTING IN A VALUE OF 17657.47 MIU/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE WAS AGAIN REPEATED USING THE ABBOTT ARCHITECT METHOD (BHCG QUANTITATIVE) RESULTING IN A VALUE OF 18659.95 MIU/ML, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS DEEMED CORRECT. PATIENT 2: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN AN HCG STAT VALUE OF 62357 MIU/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY USING THE ABBOTT ARCHITECT METHOD (BHCG QUANTITATIVE) RESULTING IN A VALUE OF 96139.89 MIU/ML, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HCG STAT REAGENT LOT WAS 628293 WITH AN EXPIRATION DATE OF 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283707 ↗
• MalfunctionJan 13, 2023High Test Results; Low Test Results; No Apparent Adverse Event; Non Reproducible Results; High Test Results; Low Test Results; No Apparent Adverse Event; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT TEST SYSTEM RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2022, PATIENT 1 HAD AN INITIAL HCG RESULT OF < 1.00 MIU/ML WITH FLAG. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 689.6 MIU/ML. ON (B)(6) 2022, PATIENT 2 HAD AN INITIAL HCG RESULT OF 1.73 MIU/ML WITH FLAG. THE SAMPLE WAS REPEATED FOUR TIMES AND THE REPEAT RESULTS WERE 1866 MIU/ML WITH FLAG, 1.15 MIU/ML WITH FLAG, 2.00 MIU/ML WITH FLAG, AND 2324 MIU/ML WITH FLAG. IT IS UNKNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE HCG REAGENT LOT IS 628293 AND THE EXPIRATION DATE IS 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162674 ↗