Alinity m System, Part No. 08N53-002
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- December 6, 2021
- Recall Number
- Z-0461-2022
- Quantity
- 742 devices
- Firm Location
- Des Plaines, IL
Reason for Recall
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Distribution
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.
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 an attached Product Correction 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 assesses and/or corrects the board values on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.