Recall Z-1576-2025 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Abbott Diagnostics Scarborough, Inc.
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
| Date | Apr 15, 2025 (initiated Mar 4, 2025) |
| Status | Open, Classified |
| Reason | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| Root cause | Process change control |
| Action | On March 4, 2025 PRODUCT REMOVAL NOTICE letters were sent to distributors. Necessary Actions to be Taken by Distributor: 1. If you have impacted inventory held in stock, then: "Immediately quarantine impacted product per your local procedure. "Complete and return the Distributor Acknowledgment Form (Form must be completed, signed and returned to receive replacement product). "Contact Customer Service to arrange return of your product by Abbott. 2. If you have forwarded the product listed above to others within your distribution network, then: "Inform them of this Product Removal Notice and pr |
| Quantity | 442,296 eaches |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit Alere Scarborough, Inc., Aug 18, 2016 |