medical Class II Updated 2018-07-18

Dako North America Inc. recalls PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to det

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, WI

Lot/Code Info: Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199

View official government recall

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