medical Class II Updated 2022-01-12

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

Recalled Product

Alinity m System, Part No. 08N53-002


Hazard / Issue

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

Issued by

FDA

Distribution: 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
Lot/Code Info: Alinity m System, Model 08N53-002, all serial numbers
View official government recall

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