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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 Kitsee related information
Date Initiated by FirmApril 24, 2023
Date PostedJune 08, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1696-2023
Recall Event ID 92271
510(K)NumberK052407 
Product Classification System, test, thyroid autoantibody - Product Code JZO
ProductAlinity 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
FEI Number 3008344661
Recalling Firm/
Manufacturer		 Abbott Ireland Limited
Finisklin Business & Technology Park
Sligo Ireland
For Additional Information ContactSuchin 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
ActionOn 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 Commerce110 kits
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = JZO
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