# FDA recall Z-1576-2025

> **Abbott Diagnostics Scarborough, Inc.** · Class II · device recall initiated 2025-03-04.

## 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

## Reason for recall

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1576-2025
- **Recalling firm:** Abbott Diagnostics Scarborough, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-04
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scarborough, ME, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2025

## Citation

> AI Analytics. FDA recall Z-1576-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1576-2025. Source: US FDA. Licensed CC0.

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