# FDA recall Z-2163-2020

> **Hologic, Inc** · Class II · device recall initiated 2019-10-10.

## Product

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution  and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

## Reason for recall

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

## Distribution

US:  AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI   OUS:  AU, CA

## Key facts

- **Recall number:** Z-2163-2020
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-10
- **Report date:** 2020-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2020

## Citation

> AI Analytics. FDA recall Z-2163-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2163-2020. Source: US FDA. Licensed CC0.

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