Dako North America Inc.: Medical Device Recall in 2018 - (Recall #: Z-2425-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 2, 2018

Date Posted: July 18, 2018

Recall Number: Z-2425-2018

Event ID: 79602

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.

Status: Terminated

Product Quantity: 1051 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated