Brand Name: ID NOW COVID-19 2 — Class II medical device recall Z-1574-2025
Ongoing recall by Abbott Diagnostics Scarborough, Inc., reported 2025-04-23, distributed nationwide. the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
| Recall number | Z-1574-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diagnostics Scarborough, Inc., Scarborough, ME, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-04-15 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 2,164,872 eaches |
| UPC / GTIN / UDI-DI | 10811877011351 |
| Lot numbers | 000M884910, 000M885121, 000M911157, 000M913147, 000M913159, 000M913227, 000M913286, 000M913303, 000M913641, 000M914188, 000M914221, 000M914852, 000M915373, 000M916267, 000M921404, 000M922204, 000M922578, 000M922601, 000M922634, 000M922950, 000M922988, 000M924019, 000M924048, 000M924386, 000M925615, 000M926188, 000M938692, 00M922634A, 00M924048A |
| Model numbers | 192-000 |
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
Reason for recall
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1574-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.