Summary
The FDA issued a Class III for Alinity i Anti-TPO Reagent Kit, List Number 09P3521 by Abbott Ireland Limited. Reason: 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.
Details
Source
Device Recall
External ID
Z-1696-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Lot/Code Info: UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Quantity Affected: 110 kits
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).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-24
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Ireland Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Ireland Limited have FDA actions?
This is the only FDA action we have on record for Abbott Ireland Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1696-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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