Abbott Diagnostics Scarborough, Inc.: Device Recall
Recall #Z-1573-2025 · 03/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1573-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Abbott Diagnostics Scarborough, Inc.
- Status
- Ongoing
- Date Initiated
- 03/04/2025
- Location
- Scarborough, ME, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178056 eaches (147472 US, 31584 OUS)
Reason for Recall
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Product Description
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.
Other Recalls by Abbott Diagnostics Scarborough, Inc.
- Class II: Risk 03/04/2025
- Class II: Risk 03/04/2025
- Class II: Risk 03/04/2025
- Class II: Risk 03/04/2025
- Class II: Risk 03/04/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.