The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1572-2025·Announced 2025-04-23

ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates

Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.

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: The FDA classified this as a Class II device recall. The hazard involves higher invalid test result rates without any reported illnesses or injuries, representing a performance defect in a diagnostic device rather than direct harm to patients.

Plain-English summary

Abbott Diagnostics Scarborough, Inc. is recalling specific lots of the ID NOW Influenza A/B 2 24T, a nucleic acid assay used to detect Influenza A and Influenza B, due to a higher occurrence of invalid results compared to the product's Instructions for Use.

The affected product (Model 427-000) was distributed worldwide, including throughout the United States and internationally to Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, France, French Polynesia, Germany, Italy, Luxembourg, Malaysia, Netherlands, Paraguay, Poland, Qatar, Saudi Arabia, Slovenia, South Korea, Spain, Switzerland, Taiwan, the United Kingdom, and Uruguay.

A total of 592,320 units were affected, with 535,416 units distributed in the United States and 56,904 units distributed outside the United States. The recall involves 29 specific lot numbers.

Healthcare facilities and providers using affected lots should review testing results and consult the product's Instructions for Use and any communications from Abbott regarding proper use and interpretation of results.

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 / In Vitro
Hazard

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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