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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Alinity i 25OH Vitamin D Reagent Kit see related information
Date Initiated by Firm November 21, 2018
Create Date December 22, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ABBOTT LABORATORIES
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