cobas c 513 clinical chemistry analyzer 07649142001Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 04015630946327), received between Sep 12, 2018 and Sep 28, 2026 — classified as 118 malfunctions.

The most frequently reported specific device problem is “High Test Results” (87 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 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917885 ↗
• MalfunctionAug 14, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253327 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE HEMOGLOBIN A1C RESULTS FROM THE COBAS C513 ANALYZER COMMERCIAL SYSTEM. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 105 MMOL/L AND A REPEAT RESULT OF 135 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337149 ↗
• MalfunctionApr 27, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH HBA1C ON A COBAS C 513 ANALYZER. INITIAL RESULT: 6.8 %. THE SAMPLE WAS REPEATED AS THE CUSTOMER REPEATS ALL SAMPLES WITH INITIALLY ELEVATED HBA1C RESULTS WHEN THERE IS NO AVAILABLE PATIENT HISTORY. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 6.2 %. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002406 ↗
• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH HBA1C TQ GEN.4 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE CUSTOMER STATED THAT PATIENT HBA1C VALUES ARE IMPLAUSIBLE AND LACK CORRELATION TO PATIENT HISTORY OR CLINICAL PRESENTATION. THE PATIENTS HAD NO INDICATIONS OF METABOLIC SYNDROME OR PREDIABETES. NO SPECIFIC PATIENT DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413875 ↗
• MalfunctionFeb 6, 2026High Test Results; Non Reproducible Results

  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 10.5%. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 6.5% AND 6.4%. THE HIGH RESULT IN QUESTION WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLE AS THE PATIENT "NEVER HAD A HIGH RESULT BEFORE." THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276186 ↗
• MalfunctionJan 5, 2026High 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 513 ANALYZER. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 16.2%. THE SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN A VALUE OF 7.3%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956776 ↗
• MalfunctionNov 25, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FOR 1 PATIENT SAMPLE TESTED ON THE COBAS C 513 ANALYZER. INITIAL RESULT: 52.2 %. ON (B)(6) 2025: REPEAT RESULT: 4.9 % (TESTED ON A VARIANT SYSTEM). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647686 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR SEVERAL PATIENTS' SAMPLES TESTED ON A COBAS C513 ANALYZER. DISCREPANT RESULTS FOR TWO PATIENT SAMPLES WERE PROVIDED: PATIENT SAMPLE 1 INITIAL RESULT: 6.7 %. REPEAT RESULT: 7.3 %. THE REPEAT RESULT OF 7.3 % WAS DEEMED TO BE CORRECT. PATIENT SAMPLE 2 INITIAL RESULT: 6.6 %. REPEAT RESULT: 7.2 %. THE QC FAILED, PROMPTING THE REPEAT OF THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630439 ↗
• MalfunctionNov 11, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FROM FIFTY-THREE (53) PATIENT SAMPLES TESTED ON THE COBAS C 513 ANALYZER. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FROM FIVE (5) PATIENT SAMPLES: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS 7.5%. THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 5.5%. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER WAS 10.6%. THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 5.2%. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE ANALYZER WAS 13.4%. THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 8.8%. PATIENT SAMPLE 4 THE INITIAL RESULT FROM THE ANALYZER WAS 8.5%. THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 6.1%. PATIENT SAMPLE 5 THE INITIAL RESULT FROM THE ANALYZER WAS 9.4%. THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 5.6%. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520581 ↗
• MalfunctionNov 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 36.60 MMOL/MOL. THE REPEATED RESULT WAS 37.20 MMOL/MOL. ON (B)(6) 2025, THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 35 MMOL/MOL AND 40.20 MMOL/MOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478943 ↗
• MalfunctionOct 24, 2025High Test Results; Output Problem; High Test Results; Output Problem

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS C 513 ANALYZER. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: PATIENT SAMPLE 1: THE INITIAL RESULT WAS 14.89%. THE REPEAT RESULT WAS 12.89%. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 26.89%. THE REPEAT RESULT WAS 5.31%. PATIENT SAMPLE 3: THE INITIAL RESULT WAS 11.01%. THE REPEAT RESULT WAS 8.10%. THE REPEAT RESULT WAS DEEMED CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381363 ↗
• MalfunctionOct 23, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS C 513 ANALYZER. THE REPORTER PROVIDED ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT FROM THE ANALYZER WAS 8.5% THE REPEAT RESULT FROM ANOTHER C 513 ANALYZER WAS 5.47%. THE QC BECAME TOO HIGH, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365548 ↗
• MalfunctionOct 20, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH HBA1C ON A COBAS C 513 ANALYZER. SAMPLE 1: INITIAL RESULT: 7.10 %. REPEAT RESULT: 5.11 %. SAMPLE 2: INITIAL RESULT: 14.6 %. REPEAT RESULT: 5.64 %. SAMPLE 3: INITIAL RESULT: 11.87 %. REPEAT RESULT: 5.69 %. THE SAMPLES WERE REPEATED ON EITHER 18-SEP-2025 OR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335233 ↗
• MalfunctionOct 16, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 207 PATIENT SAMPLES ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE SAMPLES WERE REPEATED ON A DIFFERENT REAGENT PACK ON THE SAME ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314856 ↗
• MalfunctionSep 10, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 513 ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 3.4 %. THE LOW RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, AS THE PATIENT HAS NO HISTORY OF HEMOGLOBIN VARIANT/THALASSEMIA, AND HAD A CONSISTENT HBA1C RESULT OF ~7.4% IN THE PAST YEAR. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2025, AND THE RESULT WAS 7.4% THE INITIAL SAMPLE WAS DISCARDED AND COULD NOT BE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019184 ↗
• MalfunctionSep 5, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 1 WHOLE BLOOD PATIENT SAMPLE ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL RESULT WAS 10.2%. THE CUSTOMER QUESTIONED THE HIGH RESULT AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 5.4%. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983381 ↗
• MalfunctionSep 4, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR 2-3 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN.3 (A1CX3) ON A COBAS C 513 ANALYZER. AN EXAMPLE OF A DISCREPANT HIGH RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 7.4%. THE REPEAT RESULT WAS 5.2%. THE INITIAL RESULT WAS QUESTIONED BY THE DOCTOR. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961164 ↗
• MalfunctionAug 4, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FROM THE COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL RESULT WAS 11.8%. THE REPEAT RESULT WAS 5.3% AND WAS BELIEVED TO BE CORRECT. THE REPEAT RESULT USING D100 SYSTEM (HPLC) WAS 5.0% AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698347 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HBA1C RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 149 MMOL/L. THE REPEATED RESULT WAS 70 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586090 ↗
• MalfunctionJul 11, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ASSAY RESULTS FOR SEVEN PATIENT SAMPLES TESTED ON A COBAS C513 ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS 15.19% WHILE THE REPEAT RESULT WAS 6.04%. SAMPLE 2: THE INITIAL RESULT WAS 10.06% WHILE THE REPEAT RESULT WAS 4.91%. SAMPLE 3: THE INITIAL RESULT WAS 9.54% WHILE THE REPEAT RESULT WAS 5.78%. SAMPLE 4: THE INITIAL RESULT WAS 10.75% WHILE THE REPEAT RESULT WAS 5.40%. SAMPLE 5: THE INITIAL RESULT WAS 7.91% WHILE THE REPEAT RESULTS WERE 10.10% AND 7.99%. SAMPLE 6: THE INITIAL RESULT WAS 10.40% WHILE THE REPEAT RESULT WAS 4.74%. SAMPLE 7: THE INITIAL RESULT WAS 7.87% WHILE THE REPEAT RESULT WAS 6.01%. THE TEST WAS REPEATED DUE TO THE INITIAL RESULT NOT MATCHING PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478605 ↗
• MalfunctionJun 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS (B)(4). THE HIGH RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULT WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317944 ↗
• MalfunctionJun 12, 2025Imprecision; High Test Results; Imprecision; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR HBA1C ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 58.7 MMOL/MOL. THE REPEAT RESULT WAS 35.7 MMOL/MOL. ON (B)(6) 2025, THE SAMPLE WAS REPEATED WITH A RESULT OF 37.4 MMOL/MOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193170 ↗
• MalfunctionJun 3, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 27 PATIENTS' SAMPLES TESTED WITH THE HBA1C ON A COBAS C513 ANALYZER. THE FOLLOWING ARE 3 REPRESENTATIVE EXAMPLES: SAMPLE 1: INITIAL RESULT: 12.4 %. REPEAT RESULT: 6.0 %. SAMPLE 2: INITIAL RESULT: 9.4 %. REPEAT RESULT: 5.5 %. SAMPLE 3: INITIAL RESULT: 6.8 %. REPEAT RESULT: 5.7 %. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131216 ↗
• MalfunctionMay 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE HBA1C RESULTS FOR APPROXIMATELY 25 PATIENT SAMPLES ON A COBAS C 513 ANALYZER. FIVE EXAMPLES OF PATIENT SAMPLE RESULTS WERE PROVIDED. PATIENT 1: THE INITIAL RESULT WAS 5.83%, AND THE REPEATED RESULT WAS 11.93%. PATIENT 2: THE INITIAL RESULT WAS 5.07%, AND THE REPEATED RESULT WAS 6.68%. PATIENT 3: THE INITIAL RESULT WAS 6.15%, AND THE REPEATED RESULT WAS 5.11%. PATIENT 4: THE INITIAL RESULT WAS 6.38%, AND THE REPEATED RESULT WAS 5.44%. PATIENT 5: THE INITIAL RESULT WAS 10.4%, AND THE REPEATED RESULT WAS 7.19%. THE SAMPLES WERE REPEATED BECAUSE THE CLINICIAN QUESTIONED THE RESULTS. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034683 ↗

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