Class 2 Device Recall Alinity m System

• Date Initiated by Firm: December 09, 2022
• Date Posted: January 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1009-2023
• Recall Event ID: 91286
• PMA Number: P190025
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
• Code Information: Model Number: 08N53-002
• FEI Number: 3005248192
• Recalling Firm/ Manufacturer: Abbott Molecular, Inc.; 1300 E Touhy Ave; Des Plaines IL 60018-3315
• For Additional Information Contact: Ray Bastian; 224-361-7000
• Manufacturer Reason for Recall: The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
• FDA Determined Cause: Under Investigation by firm
• Action: On December 09, 2022, Abbott Molecular issued a Field Correction Recall/Urgent Field Safety Notice to all customers who have the Alinity m System by FedEx priority overnight express. The letter explained the problems and provided the following information: "An assessment of your Alinity m System associated with the above listed potential issues will be completed remotely if your system is currently connected to AbbottLink or alternatively via onsite inspection by an Abbott representative. If necessary, an Abbott representative will schedule time to corrected the affected ADU9s) on your Alinity m System(s). In the interim, please continue to follow your laboratory protocols for any suspected incorrect results. Following the assessment and any necessary service, an additional communication will follow. If it is determined that your instrument was impacted, please assess the impact to your laboratory in reviewing previously generated test results. This recall is to be carried out at the user/customer level. If this product has been further distributed by your facility, please notify any additional impacted customers. Please review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding the communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2."
• Quantity in Commerce: 918 units
• Distribution: x
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.