FDA Medical Device Recalls (openFDA)
Abbott Ireland Limited: Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Recall number
- Z-1696-2023
- Recalling firm
- Abbott Ireland Limited
- Product
- Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Status
- Open, Classified
- Initiated
- 2023-04-24
- Posted
- 2023-06-08
- Terminated
- not on file
- 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 of the Instructions for Use (IFU).
- Root cause
- 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
- 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.
- Lot, serial or model codes
- UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
- 510(k) numbers
- ["K052407"]
- PMA numbers
- not on file
- Product code
- JZO
- Firm FEI
- 3008344661
- Firm city
- Sligo
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28