Alinity m System, Part No. 08N53-002
FDA Recall #Z-0462-2022 — Class II — December 6, 2021
Product Description
Alinity m System, Part No. 08N53-002
Reason for Recall
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Recalling Firm
Abbott Molecular, Inc. — Des Plaines, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
742 devices
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
Code Information
Alinity m System, Model 08N53-002, all serial numbers
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.