Elecsys HCG Test System 3271749160Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04015630939022), received between Oct 31, 2018 and Aug 31, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (29 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531325 ↗
• MalfunctionFeb 26, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG+SS TEST SYSTEM ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). INITIAL RESULT: 19.49 MIU/ML. THE NURSE QUESTIONED THE INITIAL RESULT, PROMPTING THE REPEAT OF THE SAMPLE. REPEAT RESULT: <0.1 MIU/ML (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452590 ↗
• MalfunctionFeb 12, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS TEST SYSTEM RESULTS FOR 2 PATIENTS FROM THE COBAS E411 DISK ANALYZER. THE DOCTOR AND PATIENTS BELIEVED THE RESULTS DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENTS. PATIENT 1: THE PATIENT BELIEVED SHE MIGHT BE PREGNANT, BUT THE NUMBER OF MONTHS WAS UNKNOWN. THE INITIAL RESULT WAS < 1 UIU/ML, WITH A DATA FLAG. A CHROMON GRAPHIC IMMUNOASSAY FOR URINE TEST FOR BETA HCG HAD A RESULT OF "SLIGHTLY POSITIVE". (THE LOWER LIMIT IS 25.) THE DOCTOR QUESTIONED THE RESULTS AND ASKED FOR REPEAT TESTING. THE SAME SAMPLE WAS REPEATED, AND THE RESULT WAS < 1 UIU/ML WITH A DATA FLAG. PATIENT 2: THE INITIAL RESULT WAS 18 UIU/ML. A CHROMON GRAPHIC IMMUNOASSAY FOR URINE TEST FOR BETA HCG HAD A NEGATIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320558 ↗
• MalfunctionJan 8, 2026High Test Results; Low Test Results; Chemical Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E411 ANALYZER. THE INITIAL RESULT WAS 5.24 MIU/ML. THE NURSE QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS <0.100 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005363 ↗
• MalfunctionDec 11, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER. THE INITIAL RESULT WAS <5 MIU/ML WITH FLAG. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 261.5 MIU/ML WITH FLAG. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782267 ↗
• MalfunctionDec 10, 2025High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS HCG+SS TEST SYSTEM ON A COBAS E411 DISK. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN AN HCG+B VALUE OF 0.381 MIU/ML WITH A DATA FLAG INDICATING CARRYOVER. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT'S PREVIOUS RESULT WAS IN THE THOUSANDS. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 5052 MIU/ML WITH A DATA FLAG. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN AN HCG+B VALUE OF 185.5 MIU/ML WITH A DATA FLAG. THE CUSTOMER REPEATED THIS SAMPLE DUE TO THE FIRST VALUE FROM THE FIRST SAMPLE BEING QUESTIONED. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 31.21 MIU/ML WITH A DATA FLAG AND 192.9 MIU/ML WITH A DATA FLAG. THE INITIAL VALUE OF 185.5 MIU/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769327 ↗
• MalfunctionDec 8, 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+SS TEST SYSTEM ASSAY ON A COBAS 6000 E601 MODULE. SAMPLE 1: INITIAL RESULT: 0.275 MIU/ML. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, WHERE A NEW SAMPLE (SAMPLE 2) WAS DRAWN AND TESTED, RESULTING IN A DIFFERENT HCG+SS VALUE. THE RESULT OF SAMPLE 2 WAS NOT PROVIDED. SAMPLE 1 WAS THEN REPEATED TWICE, RESULTING IN REPEAT RESULTS OF 65.14 MIU/ML AND 64.28 MIU/ML. THE REPEAT RESULTS OF SAMPLE 1 AND THE RESULT OF SAMPLE 2 WERE CLOSE IN VALUES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743617 ↗
• MalfunctionNov 18, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+B RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS <0.200 IU/ML, AND THE REPEAT RESULT WAS 8748 IU/ML. THE INITIAL RESULT WAS QUESTIONED BY THE DOCTOR BECAUSE IT WAS LOW AND DID NOT MATCH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584597 ↗
• MalfunctionOct 30, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+B TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 544 MIU/ML. THE NURSE QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 104621 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426894 ↗
• MalfunctionOct 20, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+SS TEST SYSTEM RESULT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM) FOR ONE PATIENT. THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 1.01 MIU/ML. ON (B)(6) 2025: THE REPEAT RESULTS OF THE INITIAL PATIENT SAMPLE WERE 636.4 MIU/ML AND 628.3 MIU/ML. THE RESULT OF A NEW PATIENT SAMPLE TESTED AT ANOTHER LABORATORY WAS 6564 U/L (OR MIU/ML). THE NURSE QUESTIONED THE RESULT, PROMPTING THE RERUN. THE REPEAT RESULTS WERE DEEMED CORRECT, AS THEY MATCHED THE PATIENT'S CLINICAL DATA AND THE RESULT OF THE NEW PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335112 ↗
• MalfunctionMay 28, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+B TEST SYSTEM RESULT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 21.60 MIU/ML, AND THE REPEAT RESULT WAS 292.3 MIU/ML. THE INITIAL RESULT WAS REPEATED BECAUSE IT WAS QUESTIONED BY THE NURSE. THE REPEAT RESULT IS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096545 ↗
• MalfunctionMay 23, 2025High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG+BETA (HCG+B) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: 203.2 MIU/ML. 1ST REPEAT RESULT: 259.5 MIU/ML. THE PHYSICIAN QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND REQUESTED A NEW SAMPLE TO BE DRAWN AND SENT TO A DIFFERENT FACILITY FOR TESTING. THE NEW SAMPLE RESULTED IN AN HCG+B VALUE AROUND 3.51 MIU/ML. ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS THEN REPEATED, AND THE 2ND REPEAT RESULT WAS AROUND 3.51 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080575 ↗
• MalfunctionMay 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+B TEST SYSTEM RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 1.0 MIU/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 1700 MIU/ML. ON (B)(6) 2025, THE INITIAL SAMPLE WAS REPEATED, AND THE RESULT WAS 250 MIU/ML. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960790 ↗
• MalfunctionApr 28, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG+B RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 0.621 MIU/ML. THE REPEAT RESULT WAS 68,806 MIU/ML. THE DOCTOR QUESTIONED THE INITIAL RESULT, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917476 ↗
• MalfunctionDec 6, 2024Low 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+B ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 59.69 MIU/ML WITH A DATA FLAG. THE HCG TEST STRIP RESULT USING THE GOLD IMMUNOCHROMATOGRAPHY METHOD WAS A STRONG POSITIVE RESULT, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 3457 MIU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864558 ↗
• MalfunctionNov 26, 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 PLASMA SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL HCG RESULT WAS 7.21 MIU/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT WAS EXPECTED TO BE NEGATIVE PER THE PATIENT'S CLINICAL STATUS, WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS <0.100 MIU/ML WITH A DATA FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788417 ↗
• MalfunctionNov 20, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+B RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 601 MODULE. THERE WAS AN ALLEGATION OF A SUSPECTED INTERFERENCE WITH THE ELECSYS HCG+B ASSAY. THE INITIAL RESULT WAS 15.15 MIU/ML. THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING AN E601 MODULE AND THE RESULTS WERE 14.98 MIU/ML AND 14.67 MIU/ML. THE SAMPLE WAS TESTED USING THE ABBOTT METHOD AND THE RESULT WAS <1.2 MIU/ML (NEGATIVE). THE SAMPLE WAS TESTED USING THE MINDRAY METHOD AND THE RESULT WAS <0.5 MIU/ML (NEGATIVE). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AS THE QUESTIONABLE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738850 ↗
• MalfunctionOct 24, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL HCG RESULT WAS 0.991 MIU/ML. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 934.0 MIU/ML WITH FLAG. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E411 ANALYZER AND THE RESULT WAS 922 MIU/ML. THE REPEAT RESULT OF 934.0 MIU/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525000 ↗
• MalfunctionJul 1, 2024Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG+B ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN A HCG+B VALUE OF < 0.1 MIU/ML WITH A DATA FLAG. A PHYSICIAN QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED, RESULTING IN AN HCG+B VALUE OF 1484 MIU/ML. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646980 ↗
• MalfunctionJun 27, 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 2 PATIENT SERUM SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER QUESTIONED THE INITIAL HIGH RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. ON 03-JUN-2024, SAMPLE 1 HAD AN INITIAL HCG RESULT OF 9.05 MIU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 0.585 MIU/ML AND <0.100 MIU/ML. THE REPEAT RESULT OF <0.100 MIU/ML WAS DEEMED CORRECT. ON 04-JUN-2024, SAMPLE 2 HAD AN INITIAL HCG RESULT OF 44.79 MIU/ML WITH FLAG. THE REPEAT RESULT WAS <0.100 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627249 ↗
• MalfunctionJan 10, 2024High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS HCG+BETA (HCG+B) ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. INITIAL RESULT: 225 MIU/ML. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION (IN THE FIRST FEW WEEKS OF PREGNANCY). THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 30 MIU/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483180 ↗
• MalfunctionJan 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF FALSE POSITIVE ELECSYS HCG+B RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E411 MODULE. THE POSITIVE RESULT WAS QUESTIONED DUE TO IT BEING IMPOSSIBLE FOR THE PATIENT TO BE PREGNANT. THE CUSTOMER PERFORMED ADDITIONAL SAMPLE COLLECTIONS AND STILL RECEIVED POSITIVE RESULTS ON THE ROCHE E411. NUMERIC RESULT VALUES WERE NOT PROVIDED. THE CUSTOMER TRIED PROCESSING THE SAMPLE IN A HYDROPHILIC TUBE TO REMOVE ANYTHING THAT MAY CAUSE A POSITIVE RESULT, BUT THE RESULT WAS STILL POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451285 ↗
• MalfunctionDec 18, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HCG+BETA ELECSYS RESULT FROM THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 1.0 IU/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED WITH A RESULT OF 8487 IU/L. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346923 ↗
• MalfunctionNov 17, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG+B RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK CU. THE INITIAL RESULT WAS AUTO-VERIFIED AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS CORRECTED QUICKLY AS THE REPORTER KNEW THAT THE PATIENT HAD A PREGNANCY STATUS AND A POINT OF CARE (POC) TEST WAS POSITIVE. THE REPORTER USED THE SAME PLASMA TUBE AND ANOTHER SERUM SAMPLE TUBE FROM THE PATIENT FOR THE RERUNS. THE INITIAL RESULT OF THE PLASMA SAMPLE WAS 2 MIU/ML. THE FIRST REPEAT RESULT FROM THE PLASMA SAMPLE WAS >10,000 MIU/ML. THE SECOND REPEAT RESULT FROM THE SERUM SAMPLE WAS >10,000 MIU/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165131 ↗
• MalfunctionNov 17, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A ELECSYS HCG + BETA TEST SYSTEM. THE INITIAL RESULT WAS 6.57 MIU/ML. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 4806 MIU/ML. THE CUSTOMER PERFORMED INSTRUMENT MAINTENANCE AND THEN REPEATED THE SAMPLE SECOND TIME. THE SECOND REPEAT RESULT WAS 5020 MIU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162205 ↗