FDA DeviceClass IINotable

FDA Recall: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applic

Date: 2026-03-25
Brand: Abbott Diagnostics Scarborough, Inc.
Category: Medical Device
FDA Class: Class II

Description

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Hazard

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Remedy

111984 units

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