Abbott Diagnostics Scarborough, Inc.: Influenza A And Influenza B Multiplex Nucleic Acid Assay
Recall Summary Abbott's ID NOW Influenza A & B 2 test kits (Model 427-000) are being recalled because certain batches produced more invalid results than expected according to the product instructions. The affected kits were distributed nationwide across all U.S. states and Washington D.C.
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- Product
- Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
- Reason
- It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c461a6b6-24a3-4a73-a913-c89a72d81dff