ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to 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 with no reported illnesses or injuries. The hazard—higher invalid result rates—is a performance/accuracy issue rather than a direct patient safety threat, consistent with a Moderate severity classification.
Plain-English summary
Abbott Diagnostics Scarborough, Inc. is recalling specific lots of the ID NOW RSV 24T (Model 435-000), a respiratory virus panel nucleic acid assay system, due to a higher occurrence of invalid test results compared to what is described in the product's Instructions for Use.
The recalled lots are: 000M906790, 000M907271, 000M923531, 000M923879, 000M924414, 000M924430, 000M926642, 000M926679, and 000M927161. A total of 178,056 units have been distributed, with 147,472 in the United States and 31,584 internationally.
The product has been distributed worldwide, including in 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, United Kingdom, and Uruguay.
If you have this product and it is from one of the affected lots, contact Abbott Diagnostics Scarborough, Inc. for instructions on what to do.
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.
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.
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 →Related recalls
Same manufacturer · Abbott Diagnostics Scarborough, Inc.
See all →- HighAbbott ID NOW influenza test lot shows higher invalid result rates
FDA (Devices) · 2026-03-25
- ModerateID NOW COVID-19 2.0 Point-of-Care Test Device Recall
FDA (Devices) · 2025-04-23
- ModerateID NOW COVID-19 2.0 24T Point-of-Care Device Recall
FDA (Devices) · 2025-04-23
- ModerateID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates
FDA (Devices) · 2025-04-23
- ModerateID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates
FDA (Devices) · 2025-04-23
Same hazard · invalid test results
See all →- ModerateID NOW Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled
FDA (Devices) · 2025-04-23
- HighDiagnostic HPV Verification Panel Recalled Due to Quality Control Failures
FDA (Devices) · 2025-02-19
- HighPanther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
FDA (Devices) · 2025-01-22
- HighFDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
FDA (Devices) · 2024-08-14
- HighPulmonary Heart Valve Grafts Recalled Due to Invalid Test Results
FDA (Devices) · 2024-08-14