Class 2 Device Recall Alinity s System

• Date Initiated by Firm: July 12, 2021
• Create Date: August 12, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2276-2021
• Recall Event ID: 88324
• Product Classification: Test, equipment, automated bloodborne pathogen - Product Code MZA
• Product: Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
• Code Information: Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: Dana Dominguez Schmidt; 877-422-2688
• Manufacturer Reason for Recall: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
• FDA Determined Cause: Software design
• Action: On 07/12/2021, the firm started hand-delivering an "Product Correction Urgent-Immediate Action Required" Notification to customers informing them that the Recalling Firm has identified an issue with pressure build up in the external waste tubing of the liquid waste assembly system if obstructed leading to a potential for biohazardous exposure and/or operator injury (contact with liquid waste). Customers are instructed to follow the below instruction until the Recalling Firm can upgrade the analyzers with a future system software version and a hardware component: 1. As stated in Section 8, Hazards, follow all product labeling and safety instructions in the laboratory. Always wear personal protective equipment (PPE) when operating the analyzer system, other laboratory instrumentation and equipment, and when using chemicals. 2. Adhere to the instructions listed in the Operations Manual, Section 10, to resolve message codes pertaining to waste overflow and contact Customer Service to resolve issues related to hardware failure. 3. Use caution when handling the Alinity s System external waste tubing. Avoid any configuration that could impact the free flow of the external waste and cause pressure buildup within the external waste tubing. A future software update and associated hardware upgrade will be implemented to enable external liquid waste tubing pressure monitoring and the display of the expected message code 5101 Liquid waste high pressure detected. 4. If customers have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 5. Complete and return the Customer Reply form. 6. Retain this letter for their laboratory records. If customers or any of the health care providers have questions regarding this information, U.S. Customers contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Cust
• Quantity in Commerce: 260 systems
• Distribution: Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
• 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.