Abbott Molecular, Inc.: 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).

Hazard

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.

Details from the source

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. Quantity: N/A Lot/code info: All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587

UPC codes

00884999047389, 00884999048034, 00884999047587

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.