Trinity Biotech 2326060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391516743655), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K140455); 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.

Recalls naming this device

1. Mar 17, 2021Terminated

   Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

   Z-1503-2021 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 29, 2021Unable to Obtain Readings; Unable to Obtain Readings

  LABORATORY USER INFORMED MANUFACTURER THAT CAPTIA MEASLES IGM KIT WAS REPORTING INVALID ASSAYS ON TWO KITS FROM LOT 060 DUE TO POSITIVE CONTROL VALUES BEING ABOVE THE ASSIGNED ISR RANGE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140455. One submission often covers many models, so check the product and lot details in each record.

• Z-2782-2016 · Jul 11, 2016 · Terminated
  Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD