Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002

Recalled January 12, 2022 · FDA recall Z-0461-2022 · Abbott Molecular

Hazard

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. · FDA Class II

Units

742 devices

Sold at

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.

Description

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

Product

Alinity m System, Part No. 08N53-002

Manufacturer(s)

Abbott Molecular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →