Recall Z-1571-2025 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 FIELD CORRECTION NOTICE letters were sent to end user customers. Please complete the following actions, as applicable. 1. If you have impacted inventory in stock, then: " Discontinue use of and destroy any remaining inventory of the impacted lots according to your procedures. " Complete and return the Customer Reply Form (Form must be completed, signed and returned to receive a replacement lot). " Please retain this letter for your records. 2. If you have forwarded the product listed above to others in your network, then: - Inform them of this Field Correction Notice, provide |
| Quantity | 339456 eaches (337560 US, 1896 OUS) |
| Distribution | 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 |
| 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 |