The Recall Desk
ModerateFDA (Devices)·Z-1575-2025·Announced 2025-04-23

ID NOW Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled

Abbott Diagnostics is recalling ID NOW Influenza A/B 2 24T test kits (Model 427-000) nationwide because affected lots have a higher occurrence of invalid test results than stated in the product instructions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is a performance defect (higher invalid rates) rather than a direct safety or health threat. The source does not report any illnesses, injuries, or patient harm, making this a moderate-severity, precautionary recall of a diagnostic device.

Plain-English summary

Abbott Diagnostics Scarborough, Inc., is recalling the ID NOW Influenza A/B 2 24T (Model 427-000), an influenza A and influenza B multiplex nucleic acid assay used for real-time nucleic acid testing. The recall affects 2,776,416 units that were distributed nationwide.

Affected lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. The impacted lots include: 000M889669, 000M890889, 000M916327, 000M916649, 000M916672, 000M916724, 000M917131, 000M917164, 000M917180, 000M917508, 000M917581, 000M919907, 000M921626, 000M921636, 000M921728, 000M923485, 000M926234, 000M926370, 000M927991, 000M928421, 000M929248, 000M931072, 000M934181, 000M939117, 000M939160, 000M939186, 000M939468, 000M939480, and 000M952883.

Healthcare facilities and laboratories that have received these test kits should contact Abbott Diagnostics for instructions on the recall and replacement options. The FDA classified this as a Class II recall (FDA recall number Z-1575-2025).

The recalled product

Product
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Manufacturer
Abbott Diagnostics Scarborough, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • invalid-test-results
  • test-performance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model 427-000
  • GTIN/DI 10811877010422
  • Lot 000M889669 Model 427-000
  • Lot 000M890889 Model 427-000
  • Lot 000M916327 Model 427-000
  • Lot 000M916649 Model 427-000
  • Lot 000M916672 Model 427-000
  • Lot 000M916724 Model 427-000
  • Lot 000M917131 Model 427-000
  • Lot 000M917164 Model 427-000
  • Lot 000M917180 Model 427-000
  • Lot 000M917508 Model 427-000
  • Lot 000M917581 Model 427-000
  • Lot 000M919907 Model 427-000
  • Lot 000M921626 Model 427-000
  • Lot 000M921636 Model 427-000
  • Lot 000M921728 Model 427-000
  • Lot 000M923485 Model 427-000
  • Lot 000M926234 Model 427-000
  • Lot 000M926370 Model 427-000

Distribution

Distributed nationwide across the United States.

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