[pending] Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Versi
Pending LLM rewrite. Source: FDA_DEVICE Z-1573-2025.
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 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 — 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 (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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