Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cell Marque Recalled by Leica Biosystems Richmond Inc. Due to A delay in transit may have contributed to...

Date: July 14, 2017
Company: Leica Biosystems Richmond Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Leica Biosystems Richmond Inc. directly.

Affected Products

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).

Quantity: 13

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Leica Biosystems Richmond Inc.

Leica Biosystems Richmond Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report