Z-1696-2023Class III

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Name: Z-1696-2023 Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Creator: Abbott Ireland Limited
Published: 2023-04-24
License: https://open.fda.gov/license/

Abbott Ireland / initiated 2023-04-24 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Ireland Limited began a recall of Alinity i Anti-TPO Reagent Kit, List Number 09P3521 on 2023-04-24. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1696-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-04-24
Posted: 2023-06-08
Recalling firm: Abbott Ireland
Product: Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Product code: JZO System, Test, Thyroid Autoantibody
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).
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1696-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08

Product code JZO

K052407Class IIArchitect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics / cleared 2006-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)