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

[pending] Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number

Pending LLM rewrite. Source: FDA_DEVICE Z-1575-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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 — Devices

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.

Related recalls

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