FDA recall Z-1665-2025

Abbott Molecular, Inc. · Class II · device

Product

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

Reason for recall

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 walking-path of the user.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-03-20
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2025