Abbott ID NOW Influenza A & B 2 Recall - Higher Invalid Rates, Z-1565-2026
Summary
FDA announced a Class II recall of Abbott Diagnostics Scarborough, Inc. ID NOW Influenza A & B 2 test kits (Model/Catalog Number: 427-000). The recall affects products with a higher occurrence of invalid rates compared to product Instructions for Use. Distribution was nationwide in the United States. The recall is ongoing.
What changed
FDA issued a Class II recall for Abbott ID NOW Influenza A & B 2 test kits after confirming that impacted lots exhibited higher invalid rates than specified in the product Instructions for Use. The recall applies to Model/Catalog Number 427-000 distributed nationwide in the United States.\n\nHealthcare providers and laboratories using these test kits should immediately identify any remaining inventory of affected lots, discontinue use, and contact Abbott Diagnostics Scarborough directly for return and replacement instructions. Patients who received potentially invalid test results may need to be retested. The recall is classified as ongoing.
What to do next
- Identify and quarantine affected lot numbers of ID NOW Influenza A & B 2 (427-000)
- Contact Abbott Diagnostics Scarborough for return/replacement instructions
- Report any adverse events related to invalid test results
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Abbott Diagnostics Scarborough, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1565-2026 · 20260325 · Ongoing
Product
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 Com...
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.
Source: openFDA Enforcement API
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