Abbott Ireland Limited Recall 92271
Description: Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Abbott Ireland Limited Recall 92271 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1696-2023 |
| Event ID | 92271 |
| Event Description | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 |
| Product Type | Devices |
| 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. |
| Quantity | 110 kits |
| Recall 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). |
| Device Classification | 20230614 |
| Device Code Info | UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024 |
| Center Classification Date | 20230608 |
| Recall Initiation Date | 20230424 |
| Recalling Firm | Abbott Ireland Limited |
| Initial Notification | Letter |
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