Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descri
Summary
The FDA issued a Class II for Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software by Abbott Diagnostics Scarborough, Inc.. Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use..
Details
Source
Device Recall
External ID
Z-1565-2026
Action Date
2026-03-25
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Quantity Affected: 111984 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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-09
Company
Scarborough, ME
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Diagnostics Scarborough, Inc. has 12 FDA actions in our database, including 7 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Diagnostics Scarborough, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Diagnostics Scarborough, Inc. have FDA actions?
Abbott Diagnostics Scarborough, Inc. has 12 FDA actions in our database, including 7 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1565-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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