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.
- Hazard
- invalid-test-results
- assay-performance
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.
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