Alinity i Anti-TPO Reagent Kit, List Number 09P3521
FDA Recall Z-1696-2023 · Posted 2023-06-08
Recalling FirmAbbott Ireland Limited
Recall StatusOpen, Classified
Product CodeJZO
Date Initiated2023-04-24
Product Quantity110 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).
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.