Recall Z-1574-2025 ยท QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets 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 | 2,164,872 eaches |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221925 | ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc., Aug 10, 2023 |