Tina-quant IgM Gen.2 08057923190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336121337), received between Aug 21, 2024 and Jun 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test 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.

• MalfunctionJun 27, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TUBES TESTED WITH TINA-QUANT IGM GEN.2 (IGM-2) ASSAY ON A COBAS C503 ANALYTICAL UNIT. TWO SAMPLE TUBES (SAMPLE TUBE 1 AND SAMPLE TUBE 2) WERE DRAWN FROM THE PATIENT AND TESTED. SAMPLE TUBE 1: INITIAL RESULT: 34.3 G/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 30.80 G/L (AUTOMATICALLY RERUN WITH DILUTION). SAMPLE TUBE 2 WAS TESTED IN A DIFFERENT LABORATORY: RESULT OBTAINED FROM A DIFFERENT COBAS C503: 18 G/L. RESULT OBTAINED FROM ELECTROPHORESIS: 18.0 G/L. THE PHYSICIAN QUESTIONED THE RESULTS AS THEY WERE INCONSISTENT, PROMPTING THE REPEAT OF THE SAMPLE TUBES ON (B)(6) 2025: SAMPLE TUBE 2 WAS TESTED ON A COBAS C303 AT A DIFFERENT LABORATORY, AND THE RESULT WAS 14.6 G/L. SAMPLE TUBE 1 WAS REPEATED ON THE ORIGINAL C503, RESULTING IN AN IGM-2 VALUE OF 18.0 G/L AND ACCOMPANIED BY A DATA FLAG. SAMPLE TUBE 1 WAS RERUN AFTER DILUTION, RESULTING IN AN IGM-2 VALUE OF 15.4 G/L. THE RESULT OF 18 G/L OBTAINED FROM A DIFFERENT COBAS C503 AT A DIFFERENT LABORATORY WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344595 ↗
• MalfunctionMar 3, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGM GEN.2 RESULTS FOR QC MATERIAL AND PATIENT SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 29 MG/DL AND A REPEAT RESULT OF 14.4 MG/DL. THE REPEAT RESULT WAS OBTAINED AFTER RECALIBRATING THE ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503249 ↗
• MalfunctionAug 21, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (IGM-2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.47 G/L. THE REPEAT RESULT WAS >63.0 G/L WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A MANUAL DILUTION OF 1:21 AND THE RESULT WAS 59.85 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020694 ↗

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