Recall Z-1696-2023 ยท JZO System, Test, Thyroid Autoantibody
Abbott Ireland Limited
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
| Date | Jun 8, 2023 (initiated Apr 24, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS Fisher Diagnostics, Jul 18, 2006 |