Cfas HbA1c 4528417190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630921096), received between Sep 17, 2018 and Nov 23, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 77 PATIENT SAMPLES TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT HBA1C RESULTS. THE CUSTOMER NOTED THAT THE HBA1C CALIBRATION PERFORMED ON (B)(6) 2022 HAD A LARGE JUMP IN SIGNAL VALUES. THE REAGENT PACK WAS THEN REMOVED ON (B)(6) 2022. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 10.7 % ON (B)(6) 2022 AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.9 %. THE REPEAT VALUE WAS DEEMED CORRECT. THE HBA1C REAGENT LOT NUMBER WAS 62959801, WITH AN EXPIRATION DATE OF 31-DEC-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857140 ↗
• MalfunctionSep 17, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WHICH HAD AN ERRONEOUS A1C-3 RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE COMPLAINED SAMPLE WAS TESTED EACH TIME USING A CALIBRATION FROM A DIFFERENT C.F.A.S. HBA1C CALIBRATOR LOT NUMBER. THIS MEDWATCH WILL APPLY TO CALIBRATOR LOT NUMBER 12635800. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO CALIBRATOR LOT NUMBER 16006601. THE COMPLAINED PATIENT SAMPLE INITIALLY RESULTED WITH AN A1C-3 VALUE OF 11.7 % ON (B)(6) 2018 WHEN USING A CALIBRATION PERFORMED WITH CALIBRATOR LOT 12635800. THIS INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STARTED USING CALIBRATOR LOT NUMBER 16006601 ON (B)(6) 2018. THE FIRST CALIBRATION PERFORMED WITH THIS NEW LOT FAILED. THE CUSTOMER RE-CALIBRATED AND THEN CONTROLS WERE OUTSIDE OF RANGE. THE CUSTOMER CALIBRATED A THIRD TIME AND CONTROLS WERE STILL OUTSIDE OF RANGE. THESE CONTROLS WERE MANUFACTURED BY MAS AND RECOVERY SHIFTED DOWNWARD WITH THE NEW CALIBR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881189 ↗
• MalfunctionSep 17, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WHICH HAD AN ERRONEOUS A1C-3 RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE COMPLAINED SAMPLE WAS TESTED EACH TIME USING A CALIBRATION FROM A DIFFERENT C.F.A.S. HBA1C CALIBRATOR LOT NUMBER. THIS MEDWATCH WILL APPLY TO CALIBRATOR LOT NUMBER 16006601. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO CALIBRATOR LOT NUMBER 12635800. THE COMPLAINED PATIENT SAMPLE INITIALLY RESULTED WITH AN A1C-3 VALUE OF 11.7 % ON (B)(6) 2018 WHEN USING A CALIBRATION PERFORMED WITH CALIBRATOR LOT 12635800. THIS INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STARTED USING CALIBRATOR LOT NUMBER 16006601 ON (B)(6) 2018. THE FIRST CALIBRATION PERFORMED WITH THIS NEW LOT FAILED. THE CUSTOMER RE-CALIBRATED AND THEN CONTROLS WERE OUTSIDE OF RANGE. THE CUSTOMER CALIBRATED A THIRD TIME AND CONTROLS WERE STILL OUTSIDE OF RANGE. THESE CONTROLS WERE MANUFACTURED BY MAS AND RECOVERY SHIFTED DOWNWARD WITH THE NEW CALIBR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881186 ↗