Recall Z-1572-2025— Abbott Diagnostics Scarborough, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Diagnostics Scarborough, Inc., initiated 2025-03-04. It names one FDA 510(k) clearance: K232775. Product: 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: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use..
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-04
- Firm location
- Scarborough, ME, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.