Alinity m System, Part No. 08N53-002
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- December 6, 2021
- Recall Number
- Z-0460-2022
- Quantity
- 742 devices
- Firm Location
- Des Plaines, IL
Reason for Recall
There is a potential for abnormal (non-sigmoidal) amplification curves.
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
Model 08N53-002, all serial numbers
Root Cause
Under Investigation by firm
Action Taken
On December 06, 2021 Abbott Molecular issued a 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 adjusts the customers clamp bar. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.