Tinaquant IgM Gen2 5220726190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630925742), received between Sep 27, 2023 and Feb 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K040431); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH TINA-QUANT IGM GEN.2 ASSAY ON A COBAS 8000 C702 MODULE. ON (B)(6) 2026: INITIAL RESULT: 2894.9 MG/DL (ACCOMPANIED BY AN INVALIDATING DATA FLAG). 1ST REPEAT RESULT: 2816.1 MG/DL (TESTED WITH DILUTION). ON (B)(6) 2026: THE PHYSICIAN REQUESTED THAT A PROTEIN ELECTROPHORESIS BE PERFORMED, AND THE ELECTROPHORESIS IMAGE DID NOT CORRESPOND TO THE IGM VALUE, WHICH IS AROUND 2000 MG/DL. THE ORIGINAL SAMPLE WAS THEN REPEATED, AND THE 2ND REPEAT RESULT WAS APPROXIMATELY 300 MG/DL. NO EXACT RESULT WAS PROVIDED. ON (B)(6) 2026: 3RD REPEAT RESULT: 278 MG/DL. THE 2ND REPEAT RESULT OF APPROXIMATELY 300 MG/DL WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420356 ↗
• MalfunctionJul 22, 2024Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT IGM GEN.2 ON A COBAS 8000 C702 MODULE. THE PATIENT SAMPLE WAS ANALYZED VIA ELECTROPHORESIS, RESULTING IN AN IGM VALUE OF 50 G/L ON (B)(6) 2024. WHEN THE PATIENT SAMPLE WAS TESTED ON THE C 702 ANALYZER, IT RESULTED IN VALUES OF 4.249 G/L ON (B)(6) 2024, 4.787 G/L ON (B)(6) 2024, AND 5.152 G/L ON (B)(6) 2024. THE PATIENT SAMPLE RESULTED IN AN ADDITIONAL VALUE OF 4.23 G/L WHEN TESTED ON THE C702 ANALYZER. THE SAMPLE WAS AUTOMATICALLY DILUTED ON THE ANALYZER 1:10 AND REPEATED, RESULTING IN A RAW VALUE OF 0.529 G/L ON (B)(6) 2024. THIS CALCULATES TO A FINAL VALUE OF 5.29 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795236 ↗
• MalfunctionSep 27, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH IGM-2 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN AN IGM VALUE OF 39.66 G/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED THREE ADDITIONAL TIMES USING A DECREASED SAMPLE VOLUME, RESULTING IN IGM VALUES OF 70.63 G/L WITH A DATA FLAG, 69.39 G/L, AND 69.93 G/L. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN AN IGM VALUE OF 36.93 G/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING AN INCREASED SAMPLE VOLUME, RESULTING IN AN IGM VALUE OF 0.14 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040431. One submission often covers many models, so check the product and lot details in each record.

• Z-1147-2019 · Dec 17, 2018 · Terminated
  Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM i