# FDA recall Z-3123-2017

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

## Product

Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD,   The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).

## 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-3123-2017
- **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-3123-2017

## Citation

> AI Analytics. FDA recall Z-3123-2017. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-3123-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*