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U.S. Department of Health and Human Services

Class 3 Device Recall Alinity i AntiTPO Reagent Kit

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  Class 3 Device Recall Alinity i AntiTPO Reagent Kit see related information
Date Initiated by Firm April 24, 2023
Date Posted June 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-1696-2023
Recall Event ID 92271
510(K)Number K052407  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Code Information UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Recalling Firm/
Manufacturer		 Abbott Ireland Limited
Finisklin Business & Technology Park
Sligo Ireland
For Additional Information Contact Suchin Song
224-668-0343
Manufacturer Reason
for Recall		 Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On April 24, 2023, Abbott issued a Product Correction letter, via FedEx priority overnight express, for this issue. Customers were instructed to provide a copy of the Product Correction letter to the laboratory manager, supervisor or health professional responsible for the impacted product and to complete and return the Customer Reply form.
Quantity in Commerce 110 kits
Distribution US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
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.
510(K) Database 510(K)s with Product Code = JZO and Original Applicant = FISHER DIAGNOSTICS
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