Tina-quant CReactive Protein IV 07876424190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630946846), received between Dec 16, 2022 and Apr 23, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH TINA-QUANT C-REACTIVE PROTEIN IV (CRP) RESULTS FROM TWO COBAS 8000 C702 MODULES AND A COBAS 703 MODULE FOR ONE PATIENT. ALLEGEDLY, A QUESTIONABLE HIGH CRP UP TO 500 MG/L CONTRIBUTED TO PROLONGED HOSPITALIZATION, ANTIBIOTIC TREATMENT, AND BRONCHOALVEOLAR LAVAGE. ON (B)(6) 2026, THE SAME SAMPLE WAS RUN ON 3 DIFFERENT ANALYSERS. ON COBAS C702 INSTRUMENT 2, THE RESULT WAS 449 MG/L, ACCOMPANIED BY A DATA FLAG. WITH DECREASED DILUTION, THE RESULT WAS 90 MG/L. THE SAMPLE WAS ADDITIONALLY MANUALLY DILUTED 1:2, WITH RESULTS OF 84 MG/L AND 1 MG/L. ON COBAS C702 INSTRUMENT 1, THE RESULT WAS 449 MG/L. WITH DECREASED DILUTION, THE RESULT WAS 91 MG/L. ON COBAS PRO C703, THE RESULT WAS 479 MG/L. WITH DECREASED DILUTION, THE RESULT WAS 109 MG/L. ON (B)(6) 2026 (COBAS C702 OR COBAS C703), THE RESULTS WERE 214 MG/L; 1:5 DILUTION: 20.4 MG/L; 1:10 DILUTION: 20 MG/L. ADDITIONALLY, THE PATIENT'S IGG WAS ANALYSED, AND THE RESULT WAS 3.44 G/L. ON (B)(6) 2026 (COBAS C702 OR COBAS C703), THE RESULTS WERE 100 MG/L; 1:5 DILUTION: 11 MG/L; 1:10 DILUTION: 13 MG/L. WITH A COMPETITOR SYSTEM, THE CRP AIDIAN QUICK READGO, THE RESULT WAS 106 MG/L. ON A SECOND COMPETITOR S

  Patient problems: Insufficient Information

  MAUDE report 24965360 ↗
• MalfunctionJan 10, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 350 MG/L. THE SAMPLE WAS AUTOMATICALLY DILUTED BY THE ANALYZER AND REPEATED, RESULTING IN A VALUE OF 571 MG/DL. THE DILUTION FACTOR IS UNKNOWN. ON (B)(6) 2024, THE SAMPLE RESULTED IN A CRP VALUE OF 327 MG/L. THE SAMPLE WAS TESTED ON AN AIDIAN QUICK READ GO METER, RESULTING IN A CRP VALUE OF 77 MG/L. NONE OF THE RESULTS MET THE PATIENT'S CLINICAL PICTURE AS THE PATIENT WAS IN GOOD HEALTH, IN HOME CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124999 ↗
• MalfunctionNov 26, 2024Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FROM FIVE SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 8000 C702 MODULE. THE RESULTS WERE QUESTIONED AS THEY DID NOT FIT THE PATIENT'S CLINICAL PICTURE. ON (B)(6) 2024, THE RESULT WAS >700 MG/L WITH A DATA FLAG. ON (B)(6) 2024, THE RESULT WAS >700 MG/L WITH A DATA FLAG. ON (B)(6) 2024, THE RESULT WAS >700 MG/L WITH A DATA FLAG. ON (B)(6) 2024, THE RESULT WAS >700 MG/L WITH A DATA FLAG. ON (B)(6) 2024, THE RESULT AT 1:2 DILUTION WAS >700 MG/L WITH A DATA FLAG. THE PATIENT SAMPLE FROM (B)(6) 2024 WAS SENT TO ANOTHER LABORATORY THAT USES AN ABBOTT ANALYZER. THE RESULT FROM THIS ANALYZER WAS 85 MG/L WITH A DATA FLAG. THE RESULT OF THE LINEARITY STUDY USING SERIAL DILUTION DID NOT PRODUCE LINEAR RESULTS AND SUGGESTED AN INTERFERENT IN THE PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787439 ↗
• MalfunctionSep 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS' SAMPLES TESTED WITH CRP4 ASSAY ON A COBAS 8000 C702 (COBAS 2) MODULE WHEN COMPARED TO A DIFFERENT C702 MODULE. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 122.34 MG/L. REPEAT RESULT: 90.06 MG/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 108.29 MG/L. REPEAT RESULT: 82.51 MG/L. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 66.06 MG/L. REPEAT RESULT: 50.54 MG/L. SAMPLE 4 (PATIENT 4): INITIAL RESULT: 56.22 MG/L. REPEAT RESULT: 41.77 MG/L. SAMPLE 5 (PATIENT 5): INITIAL RESULT: 64.47 MG/L. REPEAT RESULT: 44.94 MG/L. SAMPLE 6 (PATIENT 6): INITIAL RESULT: 66.92 MG/L. REPEAT RESULT: 48.83 MG/L. SAMPLE 7 (PATIENT 7): INITIAL RESULT: 90.07 MG/L. REPEAT RESULT: 64.20 MG/L. QC WENT OUT OF RANGE PROMPTING THE REPEAT OF THE SAMPLES. THE SAMPLES WERE INITIALLY TESTED ON COBAS 2 AND REPEATED ON A DIFFERENT C702. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED. ON (B)(6) 2024 THE CUSTOMER ALLEGED A NEW DISCREPANT RESULT: SAMPLE 8 (PATIENT 8): INITIAL RESULT: 0.47 MG/L (TESTED ON A DIFFERENT C702). 1ST REPEAT RESULT: 0.27 MG/L (TESTED ON COBAS 2). 2ND REPEAT RESULT: 0.13 MG/L (TESTED ON AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325174 ↗
• MalfunctionAug 14, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE NEONATE PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 8000 C702 MODULE. THE CUSTOMER SUSPECTS THE SAMPLE HEMOLYSIS MAY HAVE INTERFERED WITH THE ASSAY. A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A CRP VALUE OF 102 MG/L. THE SAMPLE WAS NOT HEMOLYZED. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A CRP VALUE OF 54 MG/L. THIS RESULT WAS QUESTIONED. A HEMOLYSIS INDEX OF 705 WAS MEASURED FROM THE SAMPLE. A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A CRP VALUE OF 129 MG/L. THIS SAMPLE WAS NOT HEMOLYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985033 ↗
• MalfunctionDec 16, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 0.00 MG/DL. THE REPEAT RESULT WAS 1.19 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CRP4 REAGENT LOT NUMBER WAS 653390. THE EXPIRATION DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996628 ↗