Alinity recallZ-1696-2023 · Abbott Ireland Limited · initiated Apr 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Ireland Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1696-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 24, 2023
- Posted by the FDA
- Jun 8, 2023
- Recalling firm
- Abbott Ireland Limited
- Quantity
- 110 kits
- Product code
- JZO
- FDA submissions
- K052407
- 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.
Product description
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Code information (models, lots, serial numbers)
UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity 09P3521Abbott Ireland Diagnostics · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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