Alinity m System, Part No. 08N53-002
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- December 6, 2021
- Recall Number
- Z-0462-2022
- Quantity
- 742 devices
- Firm Location
- Des Plaines, IL
Reason for Recall
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
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
Root Cause
Software design
Action Taken
On December 06, 2021 Abbott Molecular issued a Product Recall letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative adjusts the amplification detection clamp height on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.