Tina-quant Cystatin C Gen.2 08105596190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336133644), received between May 2, 2025 and Jul 29, 2025 — classified as 2 malfunctions.

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

• MalfunctionJul 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF 5 QUESTIONABLE TINA-QUANT CYSTATIN C GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT WHEN COMPARED TO COMPETITOR METHODS. SEE THE ATTACHMENT PROVIDED FOR THE RESULTS. CLINICIANS WERE ALSO QUESTIONING SIGNIFICANT DISCREPANCIES BETWEEN CREATININE-BASED EGFR AND CYSTATIN C-BASED EGFR, WITH CREATININE RESULTS BEING CONSIDERED CLINICALLY ACCURATE. THE QUESTIONED PATIENT SAMPLES ARE SUSPECTED TO CONTAIN INTERFERING FACTORS AGAINST A COMPONENT OF THE TINA-QUANT CYSTATIN C GEN.2 ASSAY, LEADING TO HIGH VALUES. THE CUSTOMER STATED THAT DILUTING THE PATIENT SAMPLES ON THE ROCHE PLATFORM RESULTS IN LOWER, MORE ACCURATE VALUES. THE DILUTION RESULTS PROVIDED IN THE ATTACHMENT ARE FROM THE SAME PATIENTS AS THE INITIAL RESULTS PROVIDED. ON THE DILUTION TABLE, THERE ARE RESULTS FOR MULTIPLE SAMPLES FROM THE SAME PATIENT. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE SAMPLES USED IN THE MEASUREMENTS FROM THE FIRST TABLE WERE THE SAME SAMPLES USED IN THE MEASUREMENTS PERFORMED IN THE DILUTION TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642156 ↗
• MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH TINA-QUANT CYSTATIN C GEN.2 (CYSC2) ASSAY ON A COBAS C503 ANALYTICAL UNIT. SAMPLE 1 (PATIENT (B)(6): INITIAL RESULT: 3.38 MG/L. REPEAT RESULT: 1.26 (WHEN TESTED ON ALINITY). SAMPLE 2 (PATIENT (B)(6): INITIAL RESULT: 7.82 MG/L. REPEAT RESULT: 2.04 (WHEN TESTED ON ALINITY). THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AND REQUESTED THAT SAMPLE 1 AND SAMPLE 2 BE REPEATED. THE UNIT OF MEASUREMENT FOR THE REPEAT RESULTS WAS NOT PROVIDED. IT WAS CONFIRMED THAT SAMPLE 1 AND SAMPLE 2 CONTAINED M-COMPONENT TYPE: IGM. SAMPLE 3 (PATIENT (B)(6) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 3.19 MG/L. 1ST REPEAT RESULT: 2.02 MG/L. 2ND AND 3RD REPEAT RESULTS WERE 1.76 MG/L AND 1.56 MG/L (BOTH ACCOMPANIED BY DATA FLAGS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949562 ↗