Tina-quant Hemoglobin A1cDx Gen.3 08445699190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613336157824), received between Feb 2, 2023 and Mar 24, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH THE HBA1C ON A COBAS PURE C303 ANALYTICAL UNIT. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 7.18 %. REPEAT RESULT: 6.1 % (TESTED USING IMMUNOFLUORESCENCE METHODOLOGY). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 6.3 %. REPEAT RESULT: 4.8 % (TESTED USING IMMUNOFLUORESCENCE METHODOLOGY). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 11.4 %. 1ST AND 2ND REPEAT RESULTS WERE BOTH 9.0 % (TESTED USING IMMUNOFLUORESCENCE METHODOLOGY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677147 ↗
• MalfunctionDec 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH THE HBA1C ON A COBAS PURE C303 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT SYSTEM. INITIAL RESULT: 6.53 %. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 5.9 % (TESTED ON ANOTHER SYSTEM). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895416 ↗
• MalfunctionNov 8, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.46 %. THE REPEAT RESULT ON THE SAME ANALYZER WAS 6.03 %. THE REPEAT RESULT USING A COBAS C311 ANALYZER AND REAGENT LOT 765161 WAS 5.3 %. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641397 ↗
• MalfunctionSep 16, 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 C 503 ANALYTICAL UNIT. THE SAMPLE WAS TESTED TWICE ON THE C 503 ANALYZER, RESULTING IN HBA1C VALUES OF 6.2 % AND 6.4 %. THE SAMPLE WAS REPEATED USING A COMPETITOR SYSTEM (DM-JACK MANUFACTURED BY MINARIS-MEDICAL), RESULTING IN AN HBA1C VALUE OF 5.2 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225219 ↗
• MalfunctionMay 7, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PEDIATRIC PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT AND A COBAS PURE INSTRUMENT COMPARED TO AN UNSPECIFIED ELECTROPHORESIS METHOD. ON (B)(6) 2024 "PATIENT 2" RESULT FROM THE COBAS PURE INSTRUMENT WAS 6.2% (44.2 MMOL/MOL). ON (B)(6) 2024 THE REPEAT FROM THE C503 ANALYZER WAS 5.97% (41.7 MMOL/MOL). THE REPEAT RESULT FROM THE ELECTROPHORESIS METHOD WAS 5.6% (37 MMOL/MOL). ON (B)(6) 2024 "PATIENT 1" RESULT FROM THE C503 ANALYZER WAS 5.86% (40.5 MMOL/MOL). THE REPEAT RESULT WAS 5.72% (39 MMOL/MOL). THE REPEAT RESULT FROM THE ELECTROPHORESIS METHOD WAS 5.4% (35 MMOL/MOL). BASED ON THE REFERENCE RANGES USED BY THE CUSTOMER, THE RESULTS FROM THE COBAS C503 ANALYZER AND COBAS PURE INSTRUMENT ARE CONSIDERED HIGH RISK FOR DIABETES AND THE RESULTS FROM THE ELECTROPHORESIS METHOD ARE DEEMED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260544 ↗
• MalfunctionApr 25, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (A1CX3) ON A COBAS C 303 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 12.70%. THE REPEAT RESULT WAS 16.90%. PATIENT 2 INITIAL RESULT WAS 14.90%. THE REPEAT RESULT WAS 6.71%. PATIENT 3 INITIAL RESULT WAS 8.25%. THE REPEAT RESULT WAS 5.50%. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE RESULTS WERE QUESTIONED AND THE SAMPLES WERE REPEATED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183739 ↗
• MalfunctionApr 24, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE A1CX3 (HBA1C) RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR TEN PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. THE REPORTER COMPLAINED THAT HEALTHY PATIENTS HAD BORDERLINE TO NORMAL OR TOO HIGH HBA1C RESULTS. THE HEALTHY PATIENTS REPORTEDLY HAD RESULTS OF 5.8% TO 6.4%. NO REPEAT OR ADDITIONAL RESULTS WERE PROVIDED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL EVENT DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176354 ↗
• MalfunctionJan 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER REPORTED A POSITIVE BIAS ON THEIR PROFICIENCY RESULTS WHICH PROMPTED THEM TO PERFORMED A PATIENT COMPARISON. THE INITIAL A1C-2 WAS 6.01%. THE SAMPLE WAS REPEATED ON A C11 ANALYZER AND THE RESULT WAS 5.46%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608822 ↗
• MalfunctionDec 15, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PRO C 503 ANALYTICAL UNIT AND A COBAS PURE C 303 ANALYTICAL UNIT. THE C503 INSTRUMENT GENERALLY MEASURED HBA1C VALUES THAT WERE AROUND 1 % HIGHER THAN OTHER HOSPITALS, PARTICULARLY FOR HIGHER VALUES. THE CUSTOMER TESTED ONE PATIENT SAMPLE FOR HBA1C ON THE C503 AND C303 INSTRUMENTS. THE C503 HBA1C RESULT WAS 7.74 % AND THE C303 RESULT WAS 7.08 %. THE CUSTOMER STATED THAT THE ACTUAL VALUE BASED ON CLINICAL SYMPTOMS SHOULD BE ABOUT 7.3 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336239 ↗
• MalfunctionApr 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED WITH A1CX3 ASSAY ON A COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE FOLLOWING RESULTS WERE REPORTED: INITIAL RESULT: 10.8%, REPEATED RESULT: 9.5%. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEATED RESULT OF 9.5% DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681835 ↗
• MalfunctionFeb 2, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS' SAMPLES TESTED ON A COBAS PRO C 503 ANALYTICAL UNIT WHEN COMPARED TO PREVIOUS MEASUREMENTS. IT WAS ALLEGED THAT THE RESULTS MADE HEALTHY PATIENTS APPEAR TO BE PRE-DIABETIC AND PRE-DIABETIC PATIENTS APPEAR TO BE DIABETIC. THE PATIENTS' DISCREPANT RESULT INFORMATION WAS REQUESTED BUT NOT PROVIDED AT THIS TIME. THE REAGENT LOT NUMBER IS 64510301. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283495 ↗