Immunoglobulin M 20737771322Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630913725), received between Feb 28, 2022 and Feb 28, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K982382); 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.

• MalfunctionFeb 28, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IGM IMMUNOGLOBULIN M (IGM) ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 2.41 G/L WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. THE REPEAT RESULT WAS 2.08 G/L WITH A DATA FLAG. THE REPEAT RESULT AFTER DILUTION WAS 85.67 G/L WITH A DATA FLAG. THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618052 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982382. One submission often covers many models, so check the product and lot details in each record.

• Z-0356-2007 · Dec 15, 2006 · Terminated
  Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.