Tinaquant IgM Gen2 3507190190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630919659), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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. 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.

• MalfunctionJun 13, 2025High Test Results; Mechanical Jam; High Test Results; Mechanical Jam

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH TINA-QUANT IGM GEN.2 ON A COBAS 6000 C (501) MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN AN IGM VALUE OF > 5000 MG/DL AND IT REPEATED AS > 5000 MG/DL. ANOTHER TUBE OF THE FIRST SAMPLE WAS SENT TO ANOTHER FACILITY AND TESTED USING AN UNKNOWN METHOD, RESULTING IN AN IGM VALUE OF 1000 MG/DL. BASED ON THIS VALUE THE CUSTOMER'S TUBE WAS REPEATED. THE CUSTOMER REPEATED THE FIRST SAMPLE AND THE IGM RESULT WAS 1000 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND TESTED TWICE, EACH TIME RESULTING IN AN IGM VALUE OF > 5000 MG/DL. ANOTHER TUBE OF THE SAMPLE WAS SENT TO ANOTHER FACILITY FOR TESTING WITH AN UNKNOWN METHOD. WHEN TESTED WITH THE UNKNOWN METHOD AT THE OTHER FACILITY, THE OTHER TUBE OF THE SECOND SAMPLE RESULTED IN VALUES OF 2000 MG/DL AND 3000 MG/DL. THE TUBE WAS RE-CENTRIFUGED AND IT WAS NOTED THERE WAS A PROTEIN CLUMP IN THE SAMPLE. AFTER RE-CENTRIFUGATION, THE SAMPLE WAS REPEATED WITH THE UNKNOWN METHOD, RESULTING IN A VALUE OF 1000 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201493 ↗

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 Ig