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Recall Observatory FDA recall evidence

Device product

Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

Z-3125-2017

July 14, 2017

Class II

Product summary

Firm
Leica Biosystems Richmond Inc.
Event
Event 78055
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-3125-2017

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 PA0808, Lot No. 47795, Exp. Date 09/24/2019

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.