Class 2 Device Recall Abbott Alinity m

• Date Initiated by Firm: October 12, 2022
• Date Posted: November 18, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0268-2023
• Recall Event ID: 91001
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
• Code Information: All serial numbers
• 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: Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
• FDA Determined Cause: Under Investigation by firm
• Action: Abbott issued a Filed Correction Recall/Urgent Field Safety Notice to its consignees on October 17, 2022 by FedEx priority overnight express. The letter explained the issues, the potential hazards, and the available actions until mandatory upgrade is completed: 1. In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. Available action: This occurrence was only found in-house under non-standard operating conditions. Prior to instrument use, empty waste container. If waste overflow occurs, please follow internal bio- hazardous waste cleaning procedures. 2. Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. Available action: To help mitigate potential occurrence, the following can be done: 1) Verify that only ONE lot of sample prep kit material is on the system at a time. 2) Load one sample prep drawer at a time. Once the first drawer is scanned, verify the scanned information is correct on the SCC. After drawer 1 information has been verified to be correct, load the second drawer. After scanning, verify the correct information for drawer 2 is correct on the SCC. 3. Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. Available action: Take the module out of service per M&D 2752 or clean out the amp detect RVs via M&D 1401, Contact your Abbott representative for further guidance. 4. 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 sepa
• Quantity in Commerce: 883 units
• Distribution: Worldwide distribution.
• 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.