Elecsys Folate 07027290190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630939695), received between Nov 16, 2021 and Aug 19, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50320774 ↗
• MalfunctionJul 8, 2025Incorrect, 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 FOLATE III RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 16.80 NG/ML. THE REPEATED RESULT WAS 26.6 NG/ML THE RESULT USING A NEW REAGENT (LOT 827023) WAS 26.2 NG/ML. PATIENT 2: ON (B)(6) 2025 THE INITIAL RESULT WAS 16.10 NG/ML. THE REPEATED RESULT WAS 24.0 NG/ML. THE RESULT USING A NEW REAGENT (LOT 827023) WAS 22.9 NG/ML. THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER PERFORMED A METHOD COMPARISON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440644 ↗
• MalfunctionAug 13, 2024Failure to Recalibrate; High Test Results; High Readings; Non Reproducible Results; Failure to Recalibrate; High Test Results; High Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SIX PATIENT SAMPLES TESTED WITH ELECSYS FOLATE III ON AN UNKNOWN COBAS PURE SYSTEM. THE CUSTOMER NOTED THAT THE REAGENT LOSES STABILITY AFTER 10 DAYS AND THAT CALIBRATIONS WERE BEING REJECTED DUE TO THE CALIBRATION FACTOR. THE CUSTOMER NOTICED THAT THE INITIAL SAMPLE VALUES DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENTS, SO THE SAMPLES WERE SENT OUT TO ANOTHER LABORATORY FOR REPEAT TESTING ON AN UNKNOWN SYSTEM. THE FIRST SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF > 20 NG/ML AND IT REPEATED AS 9.21 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF > 20 NG/ML AND IT REPEATED AS 14.1 NG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF > 20 NG/ML AND IT REPEATED AS 10.9 NG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF 18 NG/ML AND IT REPEATED AS 6.12 NG/ML. THE FIFTH SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF 19.8 NG/ML AND IT REPEATED AS 6.77 NG/ML. THE SIXTH SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF 20 NG/ML AND IT REPEATED AS 8.61 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976394 ↗
• MalfunctionJun 21, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' PLASMA SAMPLES TESTED WITH ELECSYS FOLATE G3 (FOLATE III) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT WHEN COMPARED TO A COBAS E801 IMMUNOASSAY ANALYZER. SAMPLE 1: INITIAL RESULT: 3.3 NG/ML. REPEAT RESULT: 4.5 NG/ML (TESTED ON E801). SAMPLE 2: INITIAL RESULT: 11.2 NG/ML. REPEAT RESULT: 15.1 NG/ML (TESTED ON E801). THE COMPARISON TESTING PERFORMED TO TROUBLESHOOT LOW QC RECOVERY PROMPTED THE REPEAT OF THE SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586843 ↗
• MalfunctionJun 5, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE SAMPLES WERE INITIALLY TESTED ON ANOTHER COBAS E 801 AND THEN TESTED ON THIS ANALYZER. SAMPLE 1 INITIAL RESULT WAS 3.76 NG/ML AND THE REPEAT RESULT WAS 6.5 NG/ML SAMPLE 2 INITIAL RESULT WAS 11.0 NG/ML AND THE REPEAT RESULT WAS 15.7 NG/ML. THE CUSTOMER WAS NOT CERTAIN WHICH RESULTS WERE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472201 ↗
• MalfunctionNov 21, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FOLATE G3 ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 20 NG/ML WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WITH A DILUTION WAS 4.68 NG/ML. THE RESULT FROM A SECOND SAMPLE FROM THE PATIENT WAS 4.64 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182444 ↗
• MalfunctionAug 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF QC ISSUES FOR ELECSYS FOLATE III (FOLATE III) ON BOTH OF THEIR COBAS PURE INSTRUMENTS. THE CUSTOMER PERFORMED A PATIENT COMPARISON WITH A DIFFERENT SITE AND DISCREPANT RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE. IT IS NOT KNOWN IF THE COMPARISON DATA WAS GENERATED FOR TROUBLESHOOTING PURPOSES ONLY OR IF IT WAS USED FOR DIAGNOSTIC PURPOSES. ON (B)(6) 2023 THE RESULT FROM THE OTHER SITE USING 703979 WAS 23 NMOL/L. ON (B)(6) 2023 THE RESULT USING REAGENT LOT 703979 ON THE CUSTOMER¿S INSTRUMENT WAS 17.5 NMOL/L. ON (B)(6) 2023 THE RESULT USING REAGENT LOT 728047 ON THE CUSTOMER¿S INSTRUMENT WAS 18.2 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663371 ↗
• MalfunctionDec 21, 2022Failure to Recalibrate; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results; High Readings; Failure to Recalibrate; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; High Test Results; High Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III ASSAY RESULTS FOR 8 PATIENT SAMPLES ON A COBAS E 801 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THEY WERE HAVING CALIBRATION AND QC ISSUES. FOR PATIENT 1, THE INITIAL FOLATE RESULT WAS 15.2 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 8.05 NG/ML. FOR PATIENT 2, THE INITIAL FOLATE RESULT WAS 8.56 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 6.39 NG/ML. FOR PATIENT 3, THE INITIAL FOLATE RESULT WAS 10.5 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 7.56 NG/ML. FOR PATIENT 4, THE INITIAL FOLATE RESULT WAS 12.4 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 9.31 NG/ML. FOR PATIENT 5, THE INITIAL FOLATE RESULT WAS 10.8 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 7.67 NG/ML. FOR PATIENT 6, THE INITIAL FOLATE RESULT WAS 18.0 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND THE RESULT WAS 10.3 NG/ML. FOR PATIENT 7, THE INITIAL FOLATE RESULT WAS 10.4 NG/ML. THE SAMPLE WAS REPEATED USING A NEW REAGENT LOT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16021560 ↗
• InjuryAug 8, 2022Off-Label Use; Off-Label Use

  THERE WAS AN ALLEGATION OF AN INJURY TO THE TECHNICIAN WHILE CHECKING FOR FILM ON THE ELECSYS FOLATE III (FOLATE III) REAGENT OF A COBAS E801 MODULE SERIAL NUMBER (B)(4). A FILM ALARM OCCURRED AND THE TECHNICIAN REPORTEDLY REMOVED THE REAGENT FROM THE INSTRUMENT TO CHECK FOR BUBBLES. WHILE CHECKING THE REAGENT, THE TECHNICIAN ALLEGEDLY SPLASHED THE REAGENT IN HER EYE. THE TECHNICIAN WAS WEARING GLOVES AND A LAB COAT; SHE WAS NOT WEARING FACE OR EYE PROTECTION. THE TECHNICIAN FLUSHED HER EYE WITH WATER AND WENT TO THE URGENT CARE CENTER WHERE THEY REPORTEDLY SUGGESTED SHE SEE AN EYE SPECIALIST. THE TECHNICIAN REPORTEDLY SAW AN OPHTHALMOLOGIST WHO PROVIDED HER WITH TOBRAMYCIN EYE OINTMENT. THE OPHTHALMOLOGIST ALLEGEDLY DISCOVERED "DAMAGE" TO HER EYE BUT DID "NOT BELIEVE IT IS PERMANENT." CLARIFICATION WAS REQUESTED RELATED TO THE ALLEGED "DAMAGE" TO THE EYE BUT THE DOCTOR "DID NOT ELABORATE" ON THIS STATEMENT. THE TECHNICIAN IS CURRENTLY REPORTEDLY "DOING OK" AND IS BACK AT WORK.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chemical Exposure; Conjunctivitis

  MAUDE report 15188515 ↗
• MalfunctionNov 16, 2021High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III ASSAY RESULTS FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE >20 NG/ML AND >20 NG/ML. THE REPEAT RESULTS WITH A 1:2 DILUTION BY THE INSTRUMENT WERE 8.08 NG/ML AND 7.17 NG/ML. THE REPEAT RESULT WITH A 1:3 DILUTION WAS 7.38 NG/ML. THE REPEAT RESULT WITH A 1:4 DILUTION WAS 3.85 NG/ML. THE REPEAT RESULTS WITH A 1:5 DILUTION BY THE INSTRUMENT WERE 3.0 NG/ML AND <6.00 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821600 ↗