Abbott Diagnostics Scarborough, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 6
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1572-2025 | Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number | March 4, 2025 |
| Z-1571-2025 | Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192- | March 4, 2025 |
| Z-1573-2025 | Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Versi | March 4, 2025 |
| Z-1574-2025 | Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192- | March 4, 2025 |
| Z-1576-2025 | Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Versi | March 4, 2025 |
| Z-1575-2025 | Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number | March 4, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250273 | BinaxNOW COVID-19 Ag Card | June 13, 2025 |
| K243518 | BinaxNOW COVID-19 Antigen Self Test | February 11, 2025 |
| K232775 | ID NOW Influenza A & B 2 | October 10, 2023 |
| K221925 | ID NOW COVID-19 2.0 | August 10, 2023 |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | June 24, 2022 |
| K191534 | ID NOW Influenza A & B 2 | July 11, 2019 |