Elecsys HCG Test SystemRecalls & reported problems across all models

We found 3 models of Elecsys HCG Test System by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2018 and Aug 31, 2026 — classified as 1 injury, 81 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (64 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys HCG Test System problems

Elecsys HCG Test System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys HCG Test System 3271749160

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  39 reports
• Elecsys HCG Test System 08890587190

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  32 reports
• Elecsys HCG Test System 08890595190

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  11 reports

Recent Elecsys HCG Test System adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 5, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139198 ↗
• 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 ↗
• 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 ↗
• 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 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 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 ↗
• 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 ↗
• 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 ↗

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