FDA recall Z-2425-2018

Product

PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

Reason for recall

To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.

Distribution

AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NH, NJ, NV, NY, OH, OK, PA, TX, UT, VA, WA, and WI

Key facts

Status

Terminated

Initiation date

2018-02-02

Report date

2018-07-18

Termination date

2020-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carpinteria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2018