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