Tinaquant Transferrin ver2 3015050122Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630917419), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Insufficient Device Problem Information1
- Low Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2023Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TRSF2 (TINA-QUANT TRANSFERRIN VER. 2) ASSAY ON A COBAS 8000 C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN A TRSF2 VALUE OF 195 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2023, RESULTING IN A VALUE OF 248 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE TRSF2 REAGENT LOT WAS 63631201 WITH AN EXPIRATION DATE OF 31-MAR-2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16308604 ↗
Other TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL devices
- Tina-quant Transferrin ver. 2 08058733190Roche Diagnostics GmbH · TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL1 report
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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