Alinity i Anti-TPO Reagent Kit, List Number 09P3521
FDA device recall Z-1696-2023 · posted 2023-06-08 · Open, Classified
Recall details
- Recalling firm
- Abbott Ireland Limited
- 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).
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JZO
- Quantity affected
- 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.
- Date initiated
- 2023-04-24
- Date posted
- 2023-06-08
- Location
- Sligo, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (K052407) | Fisher Diagnostics | 2006-07-18 |