Tinaquant IgG Gen2 3507432190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630919710), received between Jun 13, 2024 and Sep 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionSep 15, 2026Non Reproducible Results

  There was an allegation of questionable Tina-quant IgG Gen.2 results from the cobas 8000 cobas c 502 module.The samples were repeated on 29-July-2026.Sample 1 initial result was 13.9 g/L, and the repeat result was 7.87 g/L.Sample 2 initial result was 15.02 g/L, and the repeat result was 2 6.9 g/L.Sample 3 initial result was 17.9 g/L, and the repeat result was 10.76 g/L.Sample 4 initial result was 4.48 g/L, and the repeat result was 9.91 g/L.Sample 5 initial result was 7.79 g/L, and the repeat result was 11.05 g/L.Sample 6 initial result was 6.58 g/L, and the repeat result was 8.92 g/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771793 ↗
• MalfunctionJun 13, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE IGG-2 TINA-QUANT IGG GEN.2 RESULTS FOR 1 PATIENT ON A COBAS 8000 COBAS C 502 MODULE. THE DOCTOR QUESTIONED THE CSF IGG RESULTS FOR THE PATIENT. THEY CLAIMED THE RESULTS WERE IMPLAUSIBLE AS THE PATIENT WAS RECEIVING AN IGG SUBSTITUTION. THE INITIAL CSF IGG RESULT WAS 76.8 MG/L. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 79.61 MG/L AND 79.61 MG/L. A SERUM SAMPLE WAS COLLECTED AT THE SAME TIME AS THE CSF SAMPLE. THE INITIAL SERUM IGG RESULT WAS 38.3 G/L AND THE REPEAT RESULT WAS 39.4 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530994 ↗