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U.S. Department of Health and Human Services

Class 2 Device Recall ID NOW" Influenza A & B 2

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 Class 2 Device Recall ID NOW" Influenza A & B 2see related information
Date Initiated by FirmFebruary 09, 2026
Date PostedMarch 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1565-2026
Recall Event ID 98400
510(K)NumberK171792 
Product Classification Influenza A and influenza B multiplex nucleic acid assay - Product Code OZE
ProductProduct 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
Code Information List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
FEI Number 1221359
Recalling Firm/
Manufacturer		 Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd
Scarborough ME 04074-8303
For Additional Information ContactVicki Assardo
+1-224-6681505
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce111984 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OZE
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