Tinaquant Ferritin Gen4 5172390190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630925308), received between Jan 5, 2023 and Oct 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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.

• MalfunctionOct 29, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT FERRITIN GEN.4 ON COBAS 8000 C702 MODULE ANALYZERS. THE SAMPLE WAS FIRST TESTED ON THE FIRST C 702 ANALYZER, RESULTING IN A FERRITIN VALUE OF 900 UG/L. THE SAMPLE WAS REPEATED ON (B)(6) 2025 ON THE SAME ANALYZER, RESULTING IN A VALUE OF 962.7 UG/L. THE SAMPLE WAS REPEATED ON A SECOND C 702 ANALYZER ON (B)(6) 2025, RESULTING IN A FERRITIN VALUE OF 862.1 UG/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AFTER A 1:50 DILUTION, RESULTING IN A VALUE OF 179098 UG/L ACCOMPANIED BY A DATA FLAG INDICATING AN ISSUE WITH REACTION KINETICS. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER USING DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 24280 UG/L ACCOMPANIED BY A DATA FLAG INDICATING AN ISSUE WITH REACTION KINETICS. THE CUSTOMER ALLEGES THAT THE LOWER FERRITIN VALUES WERE NOT FLAGGED TO INDICATE THERE WERE PROZONE ISSUES WITH THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415947 ↗
• MalfunctionJan 5, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE FERR4 (TINA-QUANT FERRITIN GEN.4) RESULTS FOR SEVERAL SAMPLES FROM ONE PATIENT, TESTED ON A COBAS 8000 C702 MODULE. IT WAS ASKED BUT IT IS UNCLEAR IF ALL RESULTS WERE MEASURED FROM THE SAME SAMPLE MATERIAL OR FROM DIFFERENT DRAWINGS. ACCORDING TO THE PHYSICIAN AND THE RESULTS OF MYELOGRAPHY, THE RESULTS DID NOT FIT TO THE PATIENT¿S CLINICAL PICTURE. ON (B)(6) 2022, THE PATIENT HAD A FERR4 VALUE OF 224.8 UG/L. ON (B)(6) 2022, THE PATIENT HAD A FERR4 VALUE OF 235.3 UG/L. ON (B)(6) 2022, THE PATIENT HAD A FERR4 VALUE OF 221.6 UG/L. ON (B)(6) 2022, THE PATIENT HAD A FERRITIN VALUE OF 5 UG/L, TESTED WITH A COMPETITOR METHOD. THIS RESULT WAS DEEMED CORRECT. ON (B)(6) 2022, THE PATIENT HAD A FERR4 VALUE OF 207.7 UG/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FERR4 REAGENT LOT WAS 63670701 WITH AN EXPIRATION DATE OF 30-APR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101356 ↗