Abbott Diagnostics Scarborough, Inc. device recall (Cls II)

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. — Status: Ongoing