Tinaquant Ferritin Gen4 4885317190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630922819), received between Sep 7, 2018 and Oct 5, 2023 — classified as 3 malfunctions.

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

• MalfunctionOct 5, 2023Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE FERR4 TINA-QUANT FERRITIN GEN.4 (FERR4) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN BECAUSE OF THE TECHNOLOGIST'S OBSERVATION. THE INITIAL RESULT FROM THE MODULE WAS 0.0 UG/L WITH A DATA FLAG. THIS RESULT WAS REPORTED AS 8 UG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE MODULE WITH THE PATIENT SAMPLE AUTODILUTED WAS 675.5 UG/L. THE SECOND REPEAT RESULT FROM ANOTHER ANALYZER WAS 663 UG/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875358 ↗
• MalfunctionJul 29, 2021High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE FERR4 TINA-QUANT FERRITIN GEN.4 RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS 6000 C 501 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 495 NG/ML. THE REPEATED RESULT RUN IN REDUCED VOLUME WAS 147 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER IS QUESTIONING AN INTERFERENCE DUE TO PREVIOUS RESULTS SHOWING THE SAME PATTERN OF AN INITIALLY HIGH RESULT REPEATING LOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12244520 ↗
• MalfunctionSep 7, 2018Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENTS TESTED FOR FERR4 TINA-QUANT FERRITIN GEN.4 (FERR4) ON A COBAS 6000 C (501) MODULE. THE DATE OF EVENT IS NOT CLEAR. THE INITIAL LOW FERR4 RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE CLINICIANS QUESTIONED THEM. THE CUSTOMER REPEATED 14 PATIENT SAMPLES BY THE ABBOTT ARCHITECT METHOD AND ALL 14 PATIENT SAMPLES WERE DISCREPANT. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C501 MODULE SERIAL NUMBER WAS (B)(4). THE CUSTOMER HAD NO CALIBRATION OR QC ISSUES. IT WAS DISCOVERED THAT THE REAGENT CASSETTE WASN'T MIXED AND TO EXCLUDE PROBLEMS WITH THE CALIBRATION CURVE, THE CUSTOMER DOWNLOADED THE APPLICATION AGAIN AND PUT IN A NEW REAGENT CASSETTE THAT WAS MIXED. AFTERWARDS, CALIBRATION AND QC WERE GOOD HOWEVER THERE WERE STILL ISSUES WITH PATIENT RESULTS. THE CUSTOMER PERFORMED ADDITIONAL PATIENT COMPARISONS AND THERE WERE DISCREPANT RESULTS BETWEEN THE C501 MODULE AND THE ABBOTT ARCHITECT METHOD AGAIN. REFER TO ATTACHED DATA FOR THESE RESULTS. THE CUSTOMER STATED THAT EACH DAY APPROXIMATELY 25% OF THE PATIENTS THEY TEST HAVE EXTREMELY LOW RESULTS AND WHEN THOS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855496 ↗