Tina-quant ß2-Microglobulin 08047430190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336119990), received between Oct 16, 2024 and Oct 16, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT 2-MICROGLOBULIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C 502 MODULE. PATIENT 1: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 6.4 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. PATIENT 2: THE INITIAL RESULT WAS INVALIDATED DUE TO HAVING A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED AND THE RESULT WAS 7.2 MG/L. THE SAMPLE WAS MANUALLY DILUTED AND THE RESULT WAS 16.8 MG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULT HAVING A DATA FLAG, AND HIGHER RESULTS WERE EXPECTED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461807 ↗