Class 2 Device Recall Alinity i 25OH Vitamin D Reagent Kit

• Date Initiated by Firm: November 21, 2018
• Create Date: December 22, 2018
• Recall Status: Terminated on April 01, 2021
• Recall Number: Z-0669-2019
• Recall Event ID: 81632
• 510(K)Number: K153375
• Product Classification: System, test, vitamin d - Product Code MRG
• Product: Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
• Code Information: UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00
• 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: Nonconforming Material/Component
• Action: The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced.
• Quantity in Commerce: 760 units
• Distribution: AR, FL, GA, MD, OK, 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 = MRG