Tina-quant CReactive Protein IV 07876033190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04015630946839), received between Apr 13, 2022 and Sep 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Chemical Problem

  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 6000 c501 module. The initial result was 0.49 mg/L. The repeat result was 55 mg/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866667 ↗
• MalfunctionOct 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER STATED THEY HAVE RECEIVED IMPLAUSIBLY LOW RESULTS FOR ONE NEWBORN PATIENT TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 6000 C501 MODULE. THE CUSTOMER AND SEVERAL CLINICIANS ALLEGE THAT THE CRP RESULTS ARE IMPLAUSIBLY LOW COMPARED TO HIGH IL-6 VALUES. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF < 0.6 MG/L AND AN IL-6 VALUE OF 302 NG/L. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF < 0.6 MG/L AND AN IL-6-NGB VALUE OF 397 NG/L. ON (B)(6) 2025, THE PATIENT HAD A CRP VALUE OF 1.0 MG/L AND AN IL-6 VALUE OF 258 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424134 ↗
• MalfunctionJul 1, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ASSAY ON A COBAS 6000 C 501 (UL) V MODULE. INITIAL RESULT: 3.00 MG/L (ACCOMPANIED BY A DATA FLAG). DATA FLAGS ACCOMPANYING OTHER TEST RESULTS, PROMPTED THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 405.5 MG/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370157 ↗
• MalfunctionJan 24, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR CRP4 ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 3.69 MG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. AS THE PATIENT HAD A CRP4 RESULT OF 179.8 MG/L TWO DAYS BEFORE, THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 80.25 MG/L AND 79.3 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573007 ↗
• MalfunctionMay 8, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 71.9 MG/L. THE SAMPLE WAS REPEATED FROM THE PRIMARY TUBE WITH A RESULT OF 244 MG/L. THE SAMPLE WAS REPEATED FROM A CUP WITH A RESULT OF 253 MG/L. IT IS NOT KNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE C501 MODULE SERIAL NUMBER WAS (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888154 ↗
• MalfunctionDec 27, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CRP4 C-REACTIVE PROTEIN GEN.4 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL CRP4 RESULT WAS 0.04 MG/DL. THE SAMPLE WAS REPEATED ON A C502 ANALYZER AND THE RESULT WAS 8 MG/DL. ANOTHER SAMPLE WAS COLLECTED AND REPEATED ON THE C501 ANALYZER. THE RESULT WAS SIMILAR TO THE C502 REPEAT RESULT. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 66134701 AND THE EXPIRATION DATE IS 30-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054671 ↗
• MalfunctionApr 13, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CRP4 (CRP) RESULTS FOR TWO PATIENTS TESTED ON A COBAS INTEGRA 400 PLUS SERIAL NUMBER (B)(4). PRIOR TO PATIENT TESTING, THE CUSTOMER CONFIRMED THE CRP QC RESULTS WERE WITHIN THE ACCEPTABLE RANGES. THE CUSTOMER INITIALLY TESTED THE TWO SAMPLES FOR CRP ON THE WAMA ANALYZER WITH IMMUNO-LATEX METHODOLOGY. DUE TO THE INITIAL CRP RESULTS BEING POSITIVE, THE SAMPLES WERE TESTED ON THE INTEGRA 400. SINCE THERE WAS A DISCREPANCY BETWEEN THE TWO METHODOLOGIES, THE CUSTOMER PERFORMED DILUTION TESTING ON THE WAMA ANALYZER. THE DILUTION RESULTS WERE REQUESTED BUT NOT PROVIDED. (B)(6). THE CUSTOMER DETERMINED THE WAMA RESULTS WERE CORRECT FOR BOTH PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14098671 ↗