# FDA recall Z-1565-2026

> **Abbott Diagnostics Scarborough, Inc.** · Class II · device recall initiated 2026-02-09.

## Product

Product Name: ID NOW" Influenza A & B 2  Model/Catalog Number: 427-000  Software Version: Not Applicable  Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique  Component: Not Applicable

## Reason for recall

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1565-2026
- **Recalling firm:** Abbott Diagnostics Scarborough, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-09
- **Report date:** 2026-03-25

- **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-1565-2026

## Citation

> AI Analytics. FDA recall Z-1565-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1565-2026. Source: US FDA. Licensed CC0.

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