Tina-quant Hemoglobin A1cDx Gen.3Recalls & reported problems across all models

We found 3 models of Tina-quant Hemoglobin A1cDx Gen.3 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Nov 4, 2022 and May 13, 2026 — classified as 61 malfunctions.

The most frequently reported specific device problem is “High Test Results” (47 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 Tina-quant Hemoglobin A1cDx Gen.3 problems

Tina-quant Hemoglobin A1cDx Gen.3 models

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

• Tina-quant Hemoglobin A1cDx Gen.3 08056668190

  Hemoglobin A1c test system
  28 reports
• Tina-quant Hemoglobin A1cDx Gen.3 07559674190

  Hemoglobin A1c test system
  22 reports
• Tina-quant Hemoglobin A1cDx Gen.3 08445699190

  ASSAY, GLYCOSYLATED HEMOGLOBIN
  11 reports

Recent Tina-quant Hemoglobin A1cDx Gen.3 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE RESULTS ALLEGEDLY DO NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE PHYSICIAN EXPECTED LOWER PATIENT RESULTS BASED ON RESULTS OBTAINED WITH A CONTINUOUS BLOOD MONITOR (CBM) DEVICE. THE PATIENT'S CONTINUOUS BLOOD MONITOR SHOWS A GLUCOSE MANAGEMENT INDICATOR RESULT BELOW 7 %. THE PATIENT'S AVERAGE CBM GLUCOSE IS 145 MG/DL. THE CBM IS REPLACED EVERY 15 DAYS AND IT CORRECTLY PLACED. ON (B)(6) 2026, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.7%. ON (B)(6) 2026, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS TESTED TWICE, EACH TIME RESULTING IN AN HBA1C VALUE OF 8.2 %. ON (B)(6) 2026, A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.9 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159408 ↗
• 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 30, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 6.9%, AND THE REPEATED RESULT WAS 6.0%. PATIENT 2: THE INITIAL RESULT WAS 8.0%, AND THE REPEATED RESULT WAS 6.9%. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS WERE HIGH. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE, AND THEY WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224633 ↗
• 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 ↗
• MalfunctionDec 15, 2025Incorrect Measurement; High Test Results; Insufficient Device Problem Information; Non Reproducible Results; Incorrect Measurement; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE HBA1C ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF (B)(4). A NEW SAMPLE COLLECTED FROM THE PATIENT HAD AN HBA1C VALUE THAT TRIGGERED A LABORATORY DELTA CHECK ALERT BASED ON THE RESULT FROM THE COMPLAINED SAMPLE. DUE TO THIS, THE SAMPLE WAS REPEATED. THE COMPLAINED SAMPLE WAS REPEATED, RESULTING IN AN HBA1C VALUE OF (B)(4). THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801327 ↗
• MalfunctionDec 3, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 6.3%, AND THE REPEAT RESULT WAS REPORTED TO BE NORMAL. THE EXACT RESULT WAS NOT PROVIDED. THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT AND WENT TO ANOTHER LABORATORY. THE NEW SAMPLE RESULT WAS 5.1%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706716 ↗
• 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 ↗
• MalfunctionJul 7, 2025Chemical Problem; Chemical Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.4 %. A DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 5.7 % AND THIS VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412976 ↗
• 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 ↗

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