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Dako North America Inc. recalls PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment o
Recalled July 18, 2018 · FDA recall Z-2425-2018 · Dako North America
Hazard
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. · FDA Class II
Units
1051 kits
Sold at
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
Description
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.
Product
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Manufacturer(s)
Dako North America Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →