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Recall Observatory FDA recall evidence

Device product

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

Z-2425-2018

February 02, 2018

Class II

Product summary

Firm
Dako North America Inc.
Event
Event 79602
Status
Terminated
Classification
Class II
Quantity
1051 kits
Official record key
device-enforcement:Z-2425-2018

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.