The Recall Desk
ModerateFDA (Devices)·Z-1576-2025·Announced 2025-04-23

ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates

Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.

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 affecting a diagnostic assay with a performance defect (higher invalid rates). No illness, injury, or death has been reported. The hazard is a potential delay in diagnosis due to invalid test results, which constitutes a moderate-severity labeling/performance issue under the rubric criteria for Class II recalls without reported harm.

Plain-English summary

Abbott Diagnostics Scarborough, Inc. is recalling nine lots of the ID NOW RSV 24T, a respiratory virus nucleic acid assay system used for diagnostic testing. The affected lots are: 000M906790, 000M907271, 000M923531, 000M923879, 000M924414, 000M924430, 000M926642, 000M926679, and 000M927161 (Model 435-000, GTIN 10811877010521).

These impacted lots have a higher occurrence of invalid test results compared to what is described in the product Instructions for Use. This means patients may receive test results that cannot be interpreted, potentially requiring repeat testing and delaying diagnosis.

The product was distributed nationwide. Healthcare facilities and laboratories using ID NOW RSV 24T should verify whether they have received any of the affected lot numbers. If they have stock from the recalled lots, they should stop using them and contact Abbott for replacement or further guidance. Patients who received invalid results from these lots may need retesting.

The recalled product

Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Manufacturer
Abbott Diagnostics Scarborough, Inc.
Category
Medical Device — Diagnostic Assay / In Vitro Test
Hazard
  • invalid-test-results
  • performance-defect

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 (11)

  • Model 435-000
  • GTIN/DI 10811877010521
  • Lot 000M906790 Model 435-000
  • Lot 000M907271 Model 435-000
  • Lot 000M923531 Model 435-000
  • Lot 000M923879 Model 435-000
  • Lot 000M924414 Model 435-000
  • Lot 000M924430 Model 435-000
  • Lot 000M926642 Model 435-000
  • Lot 000M926679 Model 435-000
  • Lot 000M927161

Distribution

Distributed nationwide across the United States.

Related recalls

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