Class 2 Device Recall Alinity i Ferritin 7P65 Assay

• Date Initiated by Firm: November 21, 2018
• Create Date: August 07, 2019
• Recall Status: Terminated on March 25, 2021
• Recall Number: Z-2208-2019
• Recall Event ID: 83341
• 510(K)Number: K983759
• Product Classification: Ferritin, antigen, antiserum, control - Product Code DBF
• Product: Alinity i Ferritin Reagent Kit, List Number 07P6530; ; The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
• Code Information: UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00
• Recalling Firm/ Manufacturer: Abbott Ireland Diagnostics Division; Lisnamuck; Co. Longford Ireland
• Manufacturer Reason for Recall: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
• FDA Determined Cause: Device Design
• Action: The firm, Abbott, initiated the recall by a "Product Recall Urgent - Immediate Action Required" letter dated 11/21/2018 to its consignees. The letter explained the product, problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units, use an alternate lot of the product if available; manually inspect each reagent cartridge in inventory before use; complete and return the Customer Reply Form via FAX #: 18007770051 or email: QAGCO@abbott.com. Even if you no longer have the instrument(s), please return the completed Customer Reply Form so that we can appropriately update our customer database; If you have forwarded the product to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter; and retain this letter for your laboratory records. The units will be replaced. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
• Quantity in Commerce: 216 units
• Distribution: US Distribution to states of: AR, FL, GA, MD, OK and VA.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DBF and Original Applicant = ABBOTT LABORATORIES