The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
2,776,416

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.

Part of a larger recall action

This product is one of 3 recalled by Abbott Diagnostics Scarborough, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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