Tinaquant Haptoglobin ver2 3005593322Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630916580), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH HAPT2 (TINA-QUANT HAPTOGLOBIN VER.2) ASSAY ON A COBAS 8000 C 502 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A HAPT2 VALUE OF 0.02 G/L. 24 HOURS LATER, THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 4.76 G/L AND 4.95 G/L. ON (B)(6) 2022, A SECOND SAMPLE FROM THE SAME PATIENT WAS MEASURED. THE SAMPLE INITIALLY RESULTED IN A HAPT2 VALUE OF 4.77 G/L. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 4.92 G/L, 4.76 G/L AND 4.82 G/L. THE INITIAL QUESTIONABLE LOW RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT WAS 642662 WITH AN EXPIRATION DATE OF 31-MAR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920590 ↗