Leica Biosystems Richmond Inc.: Medical Device Recall in 2017 - (Recall #: Z-3122-2017)

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, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.

Product Classification:

Class II

Date Initiated: July 14, 2017

Date Posted: September 20, 2017

Recall Number: Z-3122-2017

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: 10

Code Information:

Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019

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