Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to Recalled by Dako North America Inc. Due to To correct the kit's instructions for use as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dako North America Inc. directly.
Affected Products
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Quantity: 1051 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 29 states: AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MO, NV, NH, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI, DC
About Dako North America Inc.
Dako North America Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report