Tinaquant Hemoglobin A1c III 5336163190Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04015630926275), received between Nov 8, 2021 and Sep 28, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “High Test Results” (32 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Non Reproducible Results

  The initial reporter received questionable Tina-quant Hemoglobin A1c Gen.3 - Hemolysate and Whole Blood Application results for one patient sample tested on the cobas 6000 c501 module.Initial analysis yielded 8.7%.Repeat analysis yielded 5.9%.The doctor questioned the initial result, prompting the rerun.The repeat result was deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917882 ↗
• MalfunctionSep 24, 2026Low Test Results

  There was an allegation of questionable results with the Tina-quant Hemoglobin A1c Gen.3 - Hemolysate and Whole Blood Application for a patient sample tested on the cobas 4000 c311 stand alone system. The initial result was 4.89%.The repeat result was 5.95%. The repeat result was deemed correct as as it was more compatible with the patients history.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882036 ↗
• MalfunctionMay 22, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ON A COBAS INTEGRA 400 PLUS. THE CUSTOMER STATES THAT MOST PATIENT RESULTS FOR HBA1C HAVE BEEN ABOVE THE REFERENCE RANGE IN ROUTINE TESTING. THESE ARE SAMPLES FROM YOUNG PATIENTS, WITHOUT COMORBIDITIES, AND WITH NO HISTORY OF ALTERED GLYCEMIA. THE CUSTOMER HAS TRIED DIFFERENT REAGENT CASSETTES AND HAVE TRIED RECALIBRATING, BUT THE ISSUE PERSISTS. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT HBA1C RESULTS. THE PATIENT SAMPLE WAS TESTED USING REAGENT LOT 83940601, RESULTING IN AN HBA1C VALUE OF 6.02 %. THE PATIENT SAMPLE WAS TESTED USING REAGENT LOT 88803001, RESULTING IN AN HBA1C VALUE OF 5.51 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25259880 ↗
• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C 501 MODULE. THE INITIAL RESULT WAS 15.1%. THE CUSTOMER QUESTIONED THE HIGH RESULT AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 6.7%. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293802 ↗
• MalfunctionJul 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FROM THE COBAS 4000 C311 STAND-ALONE SYSTEM. THE INITIAL RESULT WAS 6.2 % AND THE REPEAT RESULT FROM A BIO-RAD D10 ANALYZER WAS 10.8%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393792 ↗
• MalfunctionJun 26, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C (HBA1C) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 5.9 % (TESTED ON ANOTHER C501). THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED AT THE SAME FACILITY AND AT A SISTER LABORATORY. 1ST REPEAT RESULT: 6.5 % (REPEATED ON THE C501). THE 2ND REPEAT RESULT OBTAINED FROM THE SISTER LABORATORY WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335964 ↗
• MalfunctionJun 26, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C (HBA1C) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 5.9 % (TESTED ON ANOTHER C501). THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED AT THE SAME FACILITY AND AT A SISTER LABORATORY. 1ST REPEAT RESULT: 6.5 % (REPEATED ON C501). THE 2ND REPEAT RESULT OBTAINED FROM THE SISTER LABORATORY WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335959 ↗
• MalfunctionJun 26, 2025High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1C (HBA1C) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: 5.9 %. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED AT THE SAME FACILITY AND AT A SISTER LABORATORY. 1ST REPEAT RESULT: 6.5 % (REPEATED ON ANOTHER C501). THE 2ND REPEAT RESULT OBTAINED FROM THE SISTER LABORATORY WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335686 ↗
• MalfunctionMay 30, 2025Calibration Problem; Calibration Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR 61 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. ONLY 2 PATIENT EXAMPLES WERE PROVIDED. PATIENT 1: THE INITIAL RESULT WAS 9.05%. THE REPEATED RESULT WAS 6.20%. PATIENT 2: THE INITIAL RESULT WAS 14.6%, AND THE REPEATED RESULT WAS 9.6% THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER'S QC FAILED. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118675 ↗
• MalfunctionMay 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FROM THE COBAS 6000 C501 MODULE. PATIENT 1 INITIAL RESULT WAS 6.0 %. ON (B)(6) 2025, THE RESULT FROM AN AFINION HBA1C ANALYZER WAS 5.4 %. ON (B)(6) 2025, PATENT 2 INITIAL RESULT WAS 5.8 %. THE RESULT FROM AN AFINION HBA1C ANALYZER WAS 4.9 %. ONE GENERAL EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 7 % AND A RESULT FROM AN AFINION HBA1C ANALYZER OF 5.8 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017466 ↗
• MalfunctionMay 5, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS INTEGRA 400 PLUS W/O ISE ANALYZER. THE INITIAL RESULT WAS 6.95 %. THE REPEAT RESULT WAS 5.75 % AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960187 ↗
• MalfunctionApr 29, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HBA1C GEN. 3 RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. PATIENT SAMPLE 1. ON (B)(6) 2025: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 12.1%. THE REPEAT RESULT MATCHED THE INITIAL RESULT. ON (B)(6) 2025: THE RESULT OF A NEW PATIENT SAMPLE WAS 4.7%. PATIENT SAMPLE 2. ON (B)(6) 2025: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 8.9%. THE REPEAT RESULT MATCHED THE INITIAL RESULT. ON (B)(6) 2025: THE RESULT OF A NEW PATIENT SAMPLE WAS 4.9%. PATIENT SAMPLE 3. ON (B)(6) 2025: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 8.9% ON (B)(6) 2025: THE RESULT OF A NEW PATIENT SAMPLE FROM ANOTHER ANALYZER WAS 4.8%. THE DOCTOR QUESTIONED THE INITIAL RESULTS AND REQUESTED A NEW PATIENT SAMPLE COLLECTION, AS THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE RESULTS OF THE NEW PATIENT SAMPLES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925236 ↗
• MalfunctionApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  1. THERE WAS AN ALLEGATION QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR TWO PATIENTS FROM THE COBAS 8000 COBAS C 502 MODULE. 2. PATIENT AGE RANGE: 32-56 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2 MALES. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925109 ↗
• MalfunctionApr 3, 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 A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT WAS 14.6% ON (B)(6) 2024, AND THE REPEAT RESULT WAS 6.8%. PATIENT 2'S INITIAL RESULT WAS 9.3% ON (B)(6) 2025, AND THE REPEAT RESULT WAS 5.6%. PATIENT 3'S INITIAL RESULT WAS 7.6% ON (B)(6) 2025, AND THE REPEAT RESULT WAS 5.4%. PATIENT 3'S QUESTIONABLE RESULT WAS REPEATED BECAUSE THE DOCTOR QUESTIONED THE RESULT. PATIENT 1 & 2 WERE REPEATED DUE TO A DELTA CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761791 ↗
• MalfunctionApr 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE TINA-QUANT HBA1C GEN. 3RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULT USING THE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) TECHNIQUE WAS 5.1. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE IN THE ANALYZER, AND THE RESULT WAS 7.3. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746002 ↗
• MalfunctionMar 26, 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 A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 9.0%, AND THE REPEAT RESULT WAS 5.5%. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED THAT IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696832 ↗
• MalfunctionJan 14, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HBALC GEN. 3 RESULT FROM THE COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 9.5%. THE PATIENT COMPLAINED ABOUT THE RESULT. THE SAME SAMPLE WAS REPEATED AND THE RESULT WAS 5.1%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149025 ↗
• MalfunctionNov 26, 2024High Test Results; Output Problem; High Test Results; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT HBA1C RESULTS FROM 1 PATIENT SAMPLE TESTED ON COBAS INTEGRA 400 PLUS ANALYZER WHEN COMPARED TO A COBAS C501 MODULE. INITIAL RESULT: 7.6 %. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 5.4 % (TESTED ON C501). THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN AND THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777577 ↗
• MalfunctionNov 18, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HBALC GEN. 3 ON A COBAS INTEGRA 400 PLUS. THE PATIENT SAMPLE RESULTED IN AN HBA1C VALUE OF 6.27 %. THE PATIENT'S TREATING DOCTOR QUESTIONED THE RESULT BECAUSE IF DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE PATIENT WAS NOT DIABETIC. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AT ANOTHER LABORATORY AND THE RESULT FOR THIS SAMPLE WAS 5.2 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709431 ↗
• MalfunctionOct 25, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HBALC GEN. 3 (HEMOGLOBIN A1C) RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULT FROM THE COBAS C311 WAS 4.9%. THE RESULT FROM A COBAS C303 AND FROM A TOSOH-G8 ANALYZER WAS 5.6%. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534444 ↗
• MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Chemical Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Chemical Problem

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENTS' WHOLE BLOOD SAMPLES TESTED WITH THE HBA1C ON A COBAS 8000 CORE UNIT. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 13.5%. REPEAT RESULT: 6.4%. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 12.4%. REPEAT RESULT: 6.8%. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 8.4%. REPEAT RESULT: 7.5%. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' MEDICAL HISTORY AND THE SAMPLES WERE THEN REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951629 ↗
• MalfunctionApr 30, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THE RESULT FROM THE ANALYZER WAS 13.44%. THE RESULT FROM THE OTHER LABORATORY WAS 6.70%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213715 ↗
• MalfunctionApr 15, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HBALC GEN. 3 RESULTS FOR ONE PATIENT FROM THE COBAS 6000 C501 MODULE THAT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE RESULT FROM THE FIRST SAMPLE WAS 6.9 %. THE REPEAT RESULT FROM THE SAME TUBE APPROXIMATELY ONE HOUR LATER WAS 6.9 %. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE DOCTORS TREATING HER BELIEVED THE RESULT WAS NOT COMPATIBLE WITH HER CLINICAL HISTORY. ON (B)(6) 2024, THE RESULT FROM A SECOND SAMPLE FROM THE PATIENT WAS 5.7 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105846 ↗
• MalfunctionMar 20, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HBALC GEN. 3 ON A COBAS INTEGRA 400 PLUS. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.52 % AND IT REPEATED AS 7.33 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 14.02 % WITH A DATA FLAG AND IT REPEATED AS 12.48 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.93 % ON (B)(6) 2024 AND IT REPEATED AS 7.5 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944815 ↗
• MalfunctionMar 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 5 PATIENT SAMPLES TESTED WITH TINA-QUANT HBALC GEN. 3 ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULTS WERE MEASURED USING TWO DIFFERENT LOTS OF HBA1C REAGENT IN COMPARISON TO RESULTS MEASURED WITH AN UNKNOWN COMPETITOR METHOD. THE FIRST SAMPLE RESULTED IN AN HBA1C VALUE OF 4.27 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 4.8 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.4 %. THE SECOND SAMPLE RESULTED IN AN HBA1C VALUE OF 4.49 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 5.08 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 5.3 %. THE THIRD SAMPLE RESULTED IN AN HBA1C VALUE OF 6.42 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 6.74 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPETITOR METHOD, IT RESULTED IN A VALUE OF 8.5 %. THE FOURTH SAMPLE RESULTED IN AN HBA1C VALUE OF 5.07 % WHEN TESTED WITH REAGENT LOT 751302 AND IT RESULTED IN A VALUE OF 5.58 % WHEN TESTED WITH REAGENT LOT 736996. WHEN TESTED WITH THE COMPET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924874 ↗