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
Reported: April 23, 2025 Initiated: March 4, 2025 #Z-1576-2025
Product Description
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
Reason for Recall
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Details
- Recalling Firm
- Abbott Diagnostics Scarborough, Inc.
- Units Affected
- 442,296 eaches
- Distribution
- US Nationwide distribution.
- Location
- Scarborough, ME
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Abbott Diagnostics Scarborough, Inc.. Units affected: 442,296 eaches.
Why was this product recalled? ▼
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Moderate. Recall number: Z-1576-2025.
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