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 Acid Assay; Real Time Nucleic Acid Component: No
Reported: April 23, 2025 Initiated: March 4, 2025 #Z-1572-2025
Product Description
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 Acid Assay; Real Time Nucleic Acid 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
- 592320 eaches (535416 US, 56904 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; Uruguay.
- Location
- Scarborough, ME
Frequently Asked Questions
What product was recalled? ▼
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 Acid Assay; Real Time Nucleic Acid Component: No. Recalled by Abbott Diagnostics Scarborough, Inc.. Units affected: 592320 eaches (535416 US, 56904 OUS).
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-1572-2025.
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