Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-3121-2017

July 14, 2017

Class II

Product summary

Firm
Leica Biosystems Richmond Inc.
Event
Event 78055
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-3121-2017

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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