Drug recall
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000…
FDA recall event 96519 · Class II · Abbott Diagnostics Scarborough, Inc.
Key facts
| Event ID | 96519 |
|---|---|
| Recall numbers | Z-1571-2025, Z-1572-2025, Z-1573-2025 |
| Recalling firm | Abbott Diagnostics Scarborough, Inc. |
| Product type | Devices |
| Products | 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…, Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic…, 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| Initiation date | Mar 4, 2025 |
| Report date | Apr 23, 2025 |
| City | Scarborough |
| State | ME |
| Country | United States |
| FEI number | 1221359 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: