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
FDA Recall Z-1565-2026 · Posted 2026-03-13
Recalling FirmAbbott Diagnostics Scarborough, Inc.
Recall StatusOpen, Classified
Product CodeOZE
Date Initiated2026-02-09
Product Quantity111984 units
Reason for Recall
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Firm Action
On or about February 9, 2026 Product Removal Notice letters were sent to customers and distributors. Actions to be taken:
" Quarantine and discontinue use of any remaining inventory of the impacted lot.
" Count how many unused kit boxes (24 tests / 1 kit box) of remaining impacted inventory require replacement.
" Complete and return the Customer Acknowledgment Form (Form must be fully completed, signed and returned to receive replacement product).
" Complete the Customer Request for Replacement Product Form.
" Customer Service will arrange replacement product and return of your product.
" Retain this letter for your records.
forward this notice to those you have further distributed or transferred product to.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.