[pending] Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-
Pending LLM rewrite. Source: FDA_DEVICE Z-1571-2025.
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 COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets 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 No 192-000
- GTIN/DI 10811877011351
- Lot 000M884910 Model No 192-000
- Lot 000M885121 Model No 192-000
- Lot 000M911157 Model No 192-000
- Lot 000M913227 Model No 192-000
- Lot 000M913286 Model No 192-000
- Lot 000M913303 Model No 192-000
- Lot 000M913641 Model No 192-000
- Lot 000M914188 Model No 192-000
- Lot 000M914221 Model No 192-000
- Lot 000M914852 Model No 192-000
- Lot 000M915373 Model No 192-000
- Lot 000M916267 Model No 192-000
- Lot 000M921404 Model No 192-000
- Lot 000M922204 Model No 192-000
- Lot 000M922578 Model No 192-000
- Lot 000M922601 Model No 192-000
- Lot 000M922634 Model No 192-000
- Lot 000M924048 Model No 192-000
Distribution
Distributed nationwide across the United States.
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