Elecsys HCG STAT Test System 3300811190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630919383), received between Jul 19, 2021 and Dec 1, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Incorrect, 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 V2 AND V3 TEST SYSTEM RESULTS FROM 1 PATIENT ON A COBAS 6000 E 601 MODULE. ON (B)(6) 2022, THE INITIAL HCG V2 RESULT WAS 1.0 MIU/ML. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT TOOK A PREGNANCY TEST AT HOME THAT WAS POSITIVE AND WAS ADVISED TO HAVE ANOTHER SAMPLE COLLECTED. THE NEW SAMPLE GAVE A RESULT OF OVER 800 MIU/ML. ON (B)(6) 2022, AN ALIQUOT OF THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 79.25 MIU/ML. THE SAMPLE WAS REPEATED USING A NEW HCG V3 REAGENT. THE ORIGINAL TUBE WAS RE-CENTRIFUGED AND ALSO REPEATED AND THE RESULT WAS 71 MIU/ML. THE REPEAT RESULT OF 79.25 MIU/ML WAS DEEMED CORRECT. THE HCG V2 REAGENT LOT IS 56666900 AND THE EXPIRATION DATE IS 31-JAN-2023. THE HCG V3 REAGENT LOT IS 62829300 AND THE EXPIRATION DATE IS 31-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900427 ↗
• MalfunctionNov 14, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG TEST SYSTEM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL HCG RESULT WAS 1.31 MIU/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT'S NURSE QUESTIONED THE RESULT BECAUSE IT DIDN'T MATCH THEIR CLINICAL PICTURE AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 264.3 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT. THE HCG REAGENT LOT IS 56666900 AND THE EXPIRATION DATE IS 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15793562 ↗
• MalfunctionNov 11, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG STAT ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE SAMPLE INITIALLY RESULTED IN A VALUE OF 1.71 IU/L AND REPEATED AS 197.9 IU/L. ON (B)(6) 2022, THE SAMPLE WAS REPEATED RESULTING IN A VALUE OF 207.3 IU/L. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT WAS 566669 WITH AN EXPIRATION DATE OF 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782558 ↗
• MalfunctionSep 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN GETTING QUESTIONABLY LOW RESULTS FOR FOUR SAMPLES FROM THE SAME PATIENT TESTED WITH THE ELECSYS HCG TEST SYSTEM VER. 2 ON A COBAS E 411 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). A FIFTH SAMPLE FROM THE SAME PATIENT ALSO HAD A QUESTIONABLE RESULT WHEN TESTED FOR HCG ON AN UNKNOWN ROCHE COBAS ANALYZER AT A SECOND SITE. ALL SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE VALUES FOR THE PATIENT HAVE BEEN CONSISTENTLY LOW AND THE PHYSICIAN QUESTIONS IF THE SAMPLES CONTAIN AN INTERFERENT TO THE ASSAY. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. IN (B)(6) 2021, A FIRST SAMPLE FROM THE PATIENT RESULTED IN AN HCG VALUE OF 2.4 MIU/ML. A FEW WEEKS AFTER THE FIRST SAMPLE, A SECOND SAMPLE FROM THE PATIENT RESULTED IN AN HCG VALUE OF 1.8 MIU/ML. A FEW WEEKS AFTER THE SECOND SAMPLE, A THIRD SAMPLE FROM THE PATIENT RESULTED IN AN HCG VALUE OF 1.3 MIU/ML. ON (B)(6) 2021, A FOURTH SAMPLE FROM THE PATIENT RESULTED IN AN HCG VALUE OF 1.0 MIU/ML. THE SAMPLE WAS ALSO SERIALLY DILUTED AND REPEATED, RESULTING IN THE FOLLOWING VALUES: 1:2 DILUTION = 1.3 MIU/ML, 1:5 DILUTION = 2.9 MIU/ML, 1:10 DILUTION = 7.9 MIU/ML, 1:20 DILUTION = 19.0 MIU/ML, 1:50

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420760 ↗
• MalfunctionJul 19, 2021Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS HCG TEST SYSTEM ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE PATIENT IS PREGNANT AND THE RESULTS DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. THE SAMPLE WAS INITIALLY TESTED WITH AN AUTOMATIC 1:100 DILUTION, RESULTING IN AN HCG VALUE OF 192.1 MIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER BELIEVED THE VALUE TO BE TOO LOW, SO THE SAMPLE WAS REPEATED WITHOUT DILUTION, RESULTING IN A VALUE OF < 0.500 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH AN AUTOMATIC 1:100 DILUTION, RESULTING IN AN HCG VALUE OF 186.0 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS ALSO REPEATED WITHOUT DILUTION, RESULTING IN A VALUE OF < 0.500 MIU/ML ACCOMPANIED BY A DATA FLAG. A VALUE OF < 0.500 MIU/ML WAS REPORTED OUTSIDE OF THE LABORATORY. THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189017 ↗