Tina-quant C-Reactive Protein IV 08057591190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336121191), received between Apr 2, 2024 and Feb 11, 2026 — classified as 5 malfunctions.

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

• MalfunctionFeb 11, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV (CRP), TOTAL PROTEIN GEN.2 (TP), AND ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER CRP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TP RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP RESULTS. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES AS THEY LOOKED LIKE THEY HAD NOT BEEN CENTRIFUGED. SAMPLE 1 HAD AN INITIAL CRP RESULT OF 0.362 MG/DL AND AN INITIAL TP RESULT OF 10.6 G/DL. THE REPEAT CRP RESULT WAS 0.62 MG/DL AND THE REPEAT TP RESULT WAS 7.0 G/DL. SAMPLE 2 HAD AN INITIAL ALP RESULT OF 159 U/L. THE REPEAT RESULT WAS 88 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315639 ↗
• MalfunctionNov 19, 2025Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR SEVERAL PATIENTS' SAMPLES TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ASSAY ON A COBAS C 503 ANALYTICAL UNIT. INITIAL RESULT: >350 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 1ST REPEAT RESULT: 510 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 2ND REPEAT RESULT: "HALF LOWER" (TESTED WITH ANOTHER REAGENT CASSETTE). NO EXACT VALUE WAS PROVIDED. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED: INITIAL RESULT: >350 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 1ST REPEAT RESULT: 510 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 2ND REPEAT RESULT: 307 MG/L. 3RD REPEAT RESULT: 220 MG/L. A CONFIRMATION ABOUT THE REPEAT RESULTS OF 307 MG/L AND 220 MG/L WAS REQUESTED, BUT HAS NOT BEEN PROVIDED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593381 ↗
• MalfunctionJul 11, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 16.3 MG/L. THE INITIAL RESULT WAS QUESTIONED, AND THE PHYSICIAN REQUESTED THAT THE SAMPLE BE REPEATED. THE REPEATED RESULTS WERE 71.5 MG/L AND 74.7 MG/L. THE RESULT OF 74.7 MG/L WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481862 ↗
• MalfunctionJun 17, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENTS TESTED FOR TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 489 MG/L WITH AN INVALIDATING DATA FLAG. THE REPEAT RESULT WAS 495 MG/L. THE DOCTOR QUESTIONED THIS RESULT AND REQUESTED A NEW SAMPLE. THE INITIAL RESULT FROM THE 2ND SAMPLE WAS 193 MG/L. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE USING A 1:3 DILUTION, AND THE RESULT WAS 185 MG/L. PATIENT 2 INITIAL RESULT WAS 289 MG/L. ON (B)(6) 2025, THE REPEAT RESULT WAS 127 MG/L. A NEW SAMPLE WAS OBTAINED, AND THE INITIAL RESULT WAS 52.5 MG/L. THE REPEAT RESULT WAS 55.8 MG/L. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE FOR PATIENT 2 ON A DIFFERENT COBAS PRO INSTRUMENT, AND THE RESULT WAS 125 MG/L. THE CUSTOMER REPEATED THE SECOND SAMPLE FOR PATIENT 2 ON A DIFFERENT COBAS PRO INSTRUMENT, AND THE RESULT WAS 51.7 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235216 ↗
• MalfunctionApr 2, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 362 MG/L (WITH A DATA FLAG). THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 34.9 MG/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 366 (WITH A DATA FLAG). THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 392 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019182 ↗