Tina-quant CReactive Protein IV 07876432190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630946853), received between Feb 28, 2023 and Feb 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN I ON A COBAS C 111 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 335.6 MG/L. THE REAGENT PACK WAS NEARLY DEPLETED AT THE TIME OF MEASUREMENT. A NEW REAGENT PACK WAS LOADED AND THE SAMPLE WAS REPEATED TWICE, RESULTING IN CRP VALUES OF 28.14 MG/L AND 28.29 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388222 ↗
• MalfunctionSep 18, 2023Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CRPL4 C-REACTIVE PROTEIN GEN.4 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. ON (B)(6) 2023, THE INITIAL CRPL4 RESULT WAS 52 MG/DL. ON (B)(6) 2023, THE PATIENT PRESENTED BACK AT THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND THIS PROMPTED THE CUSTOMER TO REPEAT THE ORIGINAL SAMPLE. THE SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 0.67 MG/DL, 58 MG/DL, AND 133 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764674 ↗
• MalfunctionFeb 28, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT TESTED WITH CRPL4 C-REACTIVE PROTEIN GEN.4 ON A COBAS C 111 ((B)(4)). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 0.71 MG/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 75.85 MG/L AND 78.31 MG/L. THE 75.85 MG/L VALUE WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456974 ↗