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

Recalled January 12, 2022 · FDA recall Z-0462-2022 · Abbott Molecular

Hazard

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. · FDA Class II

Units

742 devices

Sold at

Worldwide distribution - US distribution 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 defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

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 →