Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Model No 192-000; GTIN/DI 10811877011351; Lot 000M884910 Model No 192-000; GTIN/DI 10811877011351; Lot 000M885121 Model No 192-000; GTIN/DI 10811877011351; Lot 000M911157 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913227 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913286 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913303 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913641 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914188 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914221 Model No 192-000; GTIN/DI 10811877011351; Lot 000M914852 Model No 192-000; GTIN/DI 10811877011351; Lot 000M915373 Model No 192-000; GTIN/DI 10811877011351; Lot 000M916267 Model No 192-000; GTIN/DI 10811877011351; Lot 000M921404 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922204 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922578 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922601 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922634 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924048 Model No 192-000; GTIN/DI 10811877011351; Lot 000M925615 Model No 192-000; GTIN/DI 10811877011351; Lot 000M938692 Model No 192-000; GTIN/DI 10811877011351; Lot 00M922634A Model No 192-000; GTIN/DI 10811877011351; Lot 00M924048A ****Update 4/29/2025**** 04/29/2025 (Additional Lots): Model No 192-000; GTIN/DI 10811877011351; Lot 000M913147 Model No 192-000; GTIN/DI 10811877011351; Lot 000M913159 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922950 Model No 192-000; GTIN/DI 10811877011351; Lot 000M922988 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924019 Model No 192-000; GTIN/DI 10811877011351; Lot 000M924386 Model No 192-000; GTIN/DI 10811877011351; Lot 000M926188
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution.
Recall record
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- Product type
- Devices
- Recall number
- Z-1574-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Scarborough, ME
- Recall initiated
- 2025-03-04
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1574-2025 · Source: openFDA enforcement.