# FDA recall Z-3124-2017

> **Leica Biosystems Richmond Inc.** · Class II · device recall initiated 2017-07-14.

## Product

Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD,   The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

## Reason for recall

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

## Distribution

Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.

## Key facts

- **Recall number:** Z-3124-2017
- **Recalling firm:** Leica Biosystems Richmond Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-14
- **Report date:** 2017-09-20
- **Termination date:** 2024-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3124-2017

## Citation

> AI Analytics. FDA recall Z-3124-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3124-2017. Source: US FDA. Licensed CC0.

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