Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
FDA adverse event reports and recall history for simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings (product code QWR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 148
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 148
Reports per year
Source: FDA adverse event reports by year received, 2023–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-04-15Open, ClassifiedProcess change control
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
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
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
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Monitor simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.