Leica Biosystems Richmond Inc.: Medical Device Recall in 2017 - (Recall #: Z-3121-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

Product Classification:

Class II

Date Initiated: July 14, 2017

Date Posted: September 20, 2017

Recall Number: Z-3121-2017

Event ID: 78055

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.

Status: Terminated

Product Quantity: 3

Code Information:

Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated