Home / Recalls / Leica Biosystems Richmond Inc. / Z-3122-2017

Z-3122-2017 Class II Terminated

Recalled by Leica Biosystems Richmond Inc. — Richmond, IL

Recall Details

Product Type
Devices
Report Date
September 20, 2017
Initiation Date
July 14, 2017
Termination Date
August 2, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

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.

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 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.

Code Information

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

Other recalls by Leica Biosystems Richmond Inc.

  • Z-3126-2017 Class II — Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intend (July 14, 2017)
  • Z-3120-2017 Class II — Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is i (July 14, 2017)
  • Z-3124-2017 Class II — Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is in (July 14, 2017)
  • Z-3125-2017 Class II — Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intende (July 14, 2017)
  • Z-3123-2017 Class II — Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended f (July 14, 2017)
  • Z-3121-2017 Class II — Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is inten (July 14, 2017)
  • Z-1948-2016 Class III — Ariol is an automated scanning microscope and image analysis system. It is inten (May 6, 2016)
  • Z-2039-2016 Class III — CytoVision Image Analysis and Capture System, an automated cell-locating device. (May 2, 2016)