Tina-quant Hemoglobin A1cDx Gen.3 07559674190Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04015630942787), received between Nov 4, 2022 and Mar 5, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K160571); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 513 ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 5.43%, AND THE REPEAT RESULT WAS 4.92%. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS FOUND TO BE QUESTIONABLE BECAUSE THE CUSTOMER WAS PERFORMING REPEAT TESTING DUE TO A FAILING QC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521843 ↗
• MalfunctionJan 6, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS C513 ANALYZER COMMERCIAL SYSTEM. ONE EXAMPLE HAD AN INITIAL RESULT OF 5.44 % AND A REPEAT RESULT OF 6.05%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979942 ↗
• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 (HBA1C) ASSAY ON A COBAS C 513 ANALYZER, NOT MATCHING THE PATIENTS' CLINICAL PICTURES. PATIENT 1: INITIAL RESULT: 12.1 %. REPEAT RESULT: 5.1 % (REPEAT FROM A DIFFERENT SAMPLE DRAW). PATIENT 2: INITIAL RESULT: >15 %. REPEAT RESULT: 5.1 % OR 5.2 % (REPEAT FROM A DIFFERENT SAMPLE DRAW). PATIENT 3: INITIAL RESULT: >15.5 %. REPEAT RESULT: >15.5 % (REPEAT FROM THE ORIGINAL SAMPLE DRAW). THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' HISTORY. THE REPEAT RESULTS FOR PATIENTS 1 AND 2 WERE DEEMED TO BE CORRECT. REPORTEDLY, THE CUSTOMER NOTED TO CALL PATIENT 3 BACK FOR A NEW SAMPLE WITHDRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004558 ↗
• MalfunctionAug 18, 2025High Test Results; Appropriate Device Problem Term/Code Not Available; High Test Results; Appropriate Device Problem Term/Code Not Available

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 PATIENT SAMPLE RESULTS MEASURED IN TWO LABORATORIES ON TWO COBAS C 513 ANALYZERS. THE FIRST LABORATORY WAS EVALUATING THE C 513 HBA1C METHOD AGAINST THEIR EXISTING BIORAD D-100 METHOD. FOR THIS EVALUATION, 50 PATIENT SAMPLES WERE INITIALLY TESTED IN DUPLICATE, THEN THE SAMPLES WERE TESTED AGAIN AFTER LEFT STANDING FOR 3 HOURS. THE FOLLOWING DIFFERENCES WERE OBSERVED IN THIS EVALUATION: RUN 1 - WHEN THE 50 SAMPLES ARE MIXED, THEN TESTED ON THE C 513, THE AVERAGE DIFFERENCE VERSUS THE BIORAD METHOD WAS 2.4 MMOL/MOL. RUN 2 - WHEN THE SAME 50 SAMPLES WERE RE-TESTED ON THE C513 IMMEDIATELY AFTER RUN 1, THE AVERAGE DIFFERENCE VERSUS THE BIORAD METHOD WAS 2.7 MMOL/MOL. RUN 3 - WHEN THE SAME 50 SAMPLES WERE LEFT TO STAND FOR 3 HOURS AND RE-TESTED ON THE C 513 ANALYZER, THE AVERAGE DIFFERENCE VERSUS THE BIORAD METHOD WAS 4.7 MMOL/MOL. FOR THE EVALUATION IN THE FIRST LABORATORY, AN EXAMPLE OF DATA FOR ONE PATIENT SAMPLE IS PROVIDED FROM AMONG THE 50. THIS SAMPLE HAD DISCREPANT HBA1C RESULTS. THE SAMPLE WAS INITIALLY TESTED USING THE BIORAD METHOD ON THREE BIORAD SYSTEMS, RESULTING WITH RESPECTIVE HBA1C V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833533 ↗
• MalfunctionJul 9, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 6.36%, AND THE REPEAT RESULT FROM THE SAME SAMPLE ON (B)(6) 2025 WAS 5.31%. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456823 ↗
• MalfunctionJun 10, 2025High Test Results; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Non Reproducible Results; High Test Results; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FROM THE COBAS C 513 ANALYZER. THE PATIENT'S INITIAL RESULT ON 06-JUN-2024 WAS 9.3%. ON (B)(6) 2024, THE RESULT WAS 9.3%. ON (B)(6) 2025, THE RESULT WAS 9.5%. ON (B)(6) 2025, FROM A COBAS C 503, THE RESULT WAS 9.25%. THE DOCTOR QUESTIONED THE HISTORICAL RESULTS AS THEY DID NOT MATCH A FRUCTOSAMINE RESULT, AND THE PATIENT HAD A NORMAL BLOOD GLUCOSE RESULT. THE DOCTOR ORDERED A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) TEST BECAUSE THE HISTORICAL HBA1C RESULTS DID NOT MATCH WITH THE FRUCTOSAMINE AND NORMAL GLUCOSE RESULTS. ON (B)(6) 2025, THERE WAS A (HPLC) HBA1C RESULT OF 5.43% AND A RESULT OF 3.74% FROM AN UNKNOWN SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176049 ↗
• MalfunctionMay 30, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 23 PATIENTS' SAMPLES TESTED FOR HBA1C ON A COBAS C513 ANALYZER. THE PATIENTS WERE TESTED ON DIFFERENT DATES BETWEEN (B)(6) 2024 AND (B)(6) 2025. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES. PATIENT 1: INITIAL RESULT: 7.5 %. REPEAT RESULT: 6.9 %. PATIENT 2 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 13.8 %. REPEAT RESULT: 12.7 %. PATIENT 3 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 7.1 %. REPEAT RESULT: 6.5 %. THE SAMPLES WERE REPEATED ON DIFFERENT C513 ANALYZERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112944 ↗
• MalfunctionMay 30, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED FOR HBA1C ON A COBAS C513 ANALYZER. PATIENT 1: INITIAL RESULT: 7.7 %. REPEAT RESULT: 7.0 %. PATIENT 2 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 6.3 %. REPEAT RESULT: 5.7 %. PATIENT 3 WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 6.2 %. REPEAT RESULT: 5.6 %. THE SAMPLES WERE REPEATED ON ANOTHER C513 ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112942 ↗
• MalfunctionMay 29, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FROM THE COBAS C 513 ANALYZER AFTER HAVING AN ISSUE OF HIGH BIAS ON A CAP SURVEY. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 15.3%, WITH A REPEAT RESULT OF 14.2%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 15.5%, WITH A REPEAT RESULT OF 13.7%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.7%, WITH A REPEAT RESULT OF 7.1%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 6.8%, WITH A REPEAT RESULT OF 6.2%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 6.2%, WITH A REPEAT RESULT OF 5.6%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.6%, WITH A REPEAT RESULT OF 6.9%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.6%, WITH A REPEAT RESULT OF 7.0%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.6%, WITH A REPEAT RESULT OF 7.0%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.6%, WITH A REPEAT RESULT OF 7.0%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.3%, WITH A REPEAT RESULT OF 6.7%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 8.2%, WITH A REPEAT RESULT OF 7.5%. PATIENT (B)(6) INITIAL RESULT ON (B)(6) 2025 WAS 7.5%, WITH A REPEAT RESULT OF 6.9%. PATIENT (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104457 ↗
• MalfunctionMay 23, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3. THE SAMPLES WERE INITIALLY MEASURED ON UNKNOWN ROCHE ANALYZERS AND THE SAMPLES WERE REPEATED ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE SAMPLES WERE BEING REPEATED AS PART OF A CORRELATION STUDY. VALUES FROM THE SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN WHICH VALUES ARE CONSIDERED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.7 % AND IT REPEATED AS 6.1 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.67 % AND IT REPEATED AS 7.0 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 13.84 % AND IT REPEATED AS 12.7 %. THE FOURTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.47 % ON (B)(6) 2025 AND IT REPEATED AS 6.9 %. THE FIFTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.81 % ON (B)(6) 2025 AND IT REPEATED AS 5.2 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078873 ↗
• MalfunctionMar 12, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN.3 (A1CDX) ON A COBAS C 513 ANALYZER. PATIENT 1 INITIAL RESULT WAS 7.11%. THE REPEAT RESULT FROM A DIFFERENT C513 ANALYZER WAS 5.34%. PATIENT 2 INITIAL RESULT WAS 14.58%. THE REPEAT RESULT FROM A DIFFERENT C513 ANALYZER WAS 5.97%. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586703 ↗
• MalfunctionAug 15, 2024High Test Results; High Readings; High Test Results; High Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FROM THE COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL RESULT WAS 10.0%. ON (B)(6) 2024, THE REPEAT RESULT ON THE SAME ANALYZER WAS 6.3%, AND ON A DIFFERENT ANALYZER WAS 6.3%. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS AMENDED WITH THE REPEAT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990349 ↗
• MalfunctionMar 5, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 9.3 %. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.2 %. THE REPEAT VALUE WAS DEEMED CORRECT AND MATCHED THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839849 ↗
• MalfunctionFeb 5, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SEVEN PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE CUSTOMER NOTICED A POSITIVE BIAS IN PATIENT HBA1C RESULTS AND REPEATED THESE USING AN HPLC METHOD AND A SECOND C513 ANALYZER. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.50 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 4.80 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.20 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.70 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 5.00 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.50 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.30 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 4.70 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 5.00 %. THE FOURTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.80 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 6.20 %. WHEN REPEATED ON THE SECOND C513 ANALYZER, THE RESULT WAS 6.60 %. THE FIFTH SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.60 %. WHEN REPEATED WITH THE HPLC METHOD, THE RESULT WAS 5.00 %. WHEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639931 ↗
• MalfunctionNov 20, 2023High Test Results; Output Problem; High Test Results; Output Problem

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (A1CX3) ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 14.2%. THE REPEAT RESULT WAS 6.3%. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172801 ↗
• MalfunctionOct 13, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE RERUN ON A COBAS C 502. PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS 7.40%. THE REPEAT RESULT FROM THE C 502 WAS 6.53%. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER WAS 6.97%. THE REPEAT RESULT FROM THE C 502 WAS 5.88%. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929407 ↗
• MalfunctionSep 18, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER. PATIENT 1 INITIAL RESULT WAS 7.41% ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON A COBAS 8000 C 502 MODULE WITH A RESULT OF 5.86%. PATIENT 2 INITIAL RESULT WAS 11.03%. ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON A COBAS 8000 C 502 MODULE WITH A RESULT OF 9.51%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17766033 ↗
• MalfunctionSep 15, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 67 PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLES WERE REPEATED ON A SECOND ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17759435 ↗
• MalfunctionAug 30, 2023High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLEA1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C513 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTICED A POSITIVE BIAS ON THE ANALYZER WHEN THEY COMPARED THE RESULTS OF THE PATIENT SAMPLE. THE PATIENT STATED THAT THERE WERE TWO SAMPLES FROM THE PATIENT - SAMPLE 1 AND SAMPLE 2. THE INITIAL RESULT OF SAMPLE 1 FROM ANALYZER 2 WAS 6.3%. THE REPEAT RESULT OF SAMPLE 1 FROM ANALYZER 1 WAS 6.9% THE REPORTER PERFORMED TROUBLESHOOTING AND RAN BOTH SAMPLES ON ANALYZER 1 AND ANOTHER ANALYZER (ANALYZER 3). THE RESULTS OF SAMPLE 1 AND SAMPLE 2 FROM ANALYZER 1 WERE BOTH 6.3%. THE RESULTS OF SAMPLE 1 AND SAMPLE 2 FROM ANALYZER 3 WERE BOTH 6.6%. THE RESULT FROM ANALYZER 2 WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655413 ↗
• MalfunctionJan 20, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HEMOGLOBIN A1C RESULT FROM THE COBAS C513 ANALYZER. THE INITIAL RESULT WAS 7.2% AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN CALLED AND QUESTIONED THE RESULT BECAUSE PAST RESULTS FOR THIS PATIENT HAD BEEN CLOSER TO 5.0%. ON 30-DEC-2022, THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS 5.0%. THE REAGENT LOT NUMBER WAS 62958001 WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213818 ↗
• MalfunctionDec 1, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL HEMOGLOBIN A1C RESULT WAS 12.5%. THE SAMPLE WAS RETESTED USING HPLC AND THE RESULT WAS 4.9%. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER IS 61196701. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892633 ↗
• MalfunctionNov 4, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED QC WAS HIGH OUTSIDE OF THE ACCEPTABLE RANGE FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (A1CX3) ON THE COBAS C513 ANALYZER. THE CUSTOMER REPEATED PATIENT SAMPLES THAT HAD BEEN RUN PRIOR TO QC BEING OUT OF RANGE AND THE RESULTS WERE MUCH LOWER. THE CUSTOMER STATED APPROXIMATELY 100 PATIENT SAMPLES NEEDED CORRECTED REPORTS. THE CUSTOMER PROVIDED EXAMPLES OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 6.95%. THE REPEAT FROM A DIFFERENT C513 ANALYZER WAS 5.82%. PATIENT 2 INITIAL RESULT WAS 12.39%. THE REPEAT FROM A DIFFERENT C513 ANALYZER WAS 9.97%. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE A1CX3 REAGENT LOT NUMBER WAS 59191001 WITH AN EXPIRATION DATE OF 31-MAR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160571. One submission often covers many models, so check the product and lot details in each record.

• Z-2478-2019 · Jul 18, 2019 · Terminated
  cobas c513 Analyzer