Recall database

Real Time Nucleic Acid Amplification System recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-1665-2025

Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model…

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the wal…

Real Time Nucleic Acid Amplification System
Device Design

Abbott Molecular, Inc.ILApr 30, 2025

Class IIOngoingZ-0836-2025

Biocartis Nv recalls Idylla INSTRUMENT

False-positive MSI-H results generated by the Idylla MSI Test.

Real Time Nucleic Acid Amplification System
Environmental control

Biocartis NvJan 22, 2025