FDA recall Z-3120-2017

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

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

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.

Key facts

Status

Terminated

Initiation date

2017-07-14

Report date

2017-09-20

Termination date

2024-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3120-2017