Tina-quant Ferritin Gen.4 08057648190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336121238), received between Jul 12, 2023 and Mar 8, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024High Test Results; High Test Results
THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR FERR4 ON A COBAS C 303 ANALYTICAL UNIT COMPARED TO TWO COMPETITOR METHODS. ON 14-FEB-2024 THE INITIAL RESULT FROM THE C303 ANALYZER WAS 46.7 NG/ML. ON 15-FEB-2024 THE REPEAT RESULT FROM COMPETITOR METHOD 1 WAS 2.95 NG/ML. THE REPEAT RESULT FROM COMPETITOR METHOD 2 WAS < 3 NG/ML. A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE C 303 ANALYZER WAS 49 NG/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18866633 ↗MalfunctionJul 12, 2023Low Test Results; Low Test Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH FERR4 (FERRITIN) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER NOTED THAT CONTROLS WERE RUNNING HIGH WITH A NEW LOT OF FERRITIN REAGENT. THE SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 7 NG/ML. CONTROLS TESTED AFTER THE INITIAL SAMPLE RUN WERE OUTSIDE OF RANGE, SO THE SAMPLE WAS REPEATED. THE SAMPLE REPEATED WITH A FERRITIN VALUE OF 11 NG/ML. THIS REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17309096 ↗
Other FERRITIN, ANTIGEN, ANTISERUM, CONTROL devices
- Alinity 07P6530Abbott Ireland · FERRITIN, ANTIGEN, ANTISERUM, CONTROL1 recall7 reports
- Tinaquant Ferritin Gen4 4885317190Roche Diagnostics GmbH · FERRITIN, ANTIGEN, ANTISERUM, CONTROL3 reports
- Tinaquant Ferritin Gen4 5172390190Roche Diagnostics GmbH · FERRITIN, ANTIGEN, ANTISERUM, CONTROL2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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