Device product
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) 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
Z-3120-2017
Product summary
- Event
- Event 78055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-3120-2017
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 PA0796, Lot No. 47793, 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.