Dako PD-L1 IHC 22C3 pharmDx: Storage Time Change Recall

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Contact the company & request your remedy

Recalling firmDako North America Inc.1170 Mark Ave · Carpinteria, CA 93013-2918

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Dako is recalling certain PD-L1 IHC 22C3 pharmDx kits because the storage time for gastric and gastroesophageal junction adenocarcinoma tissue sections has been reduced from six months to five months. This change affects patient treatment decisions and requires updated handling procedures.

Why it’s dangerous

The recall involves a change in storage time for tissue sections used in cancer testing. This update ensures accurate PD-L1 level measurements for patient treatment decisions, but does not pose a safety hazard.

Who’s affected

Pathologists and lab technicians who use Dako PD-L1 IHC 22C3 pharmDx kits for cancer testing are affected. Those handling the specific lot numbers listed are most at risk.

How to tell if you have this one

Check the lot numbers on the kit: 10127731A, 10126716C, 10127741, 10129051, and 10132199. The product is used for determining PD-L1 levels in cancer treatment.

Brand
Dako
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Storage Time
Verify the storage time for gastric and gastroesophageal junction adenocarcinoma tissue sections in the kit instructions.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to a change in storage time for tissue sections from six months to five months to ensure accurate PD-L1 level measurements for cancer treatment.

Which lot numbers are affected?

Lot numbers 10127731A, 10126716C, 10127741, 10129051, and 10132199 are affected.

Is there a risk of injury from this product?

No, this is a procedural update for accurate testing and does not pose a safety hazard.

Take action

Contact Dako

We’ve drafted a message you can send Dako to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2425-2018 — Dako Dako

Hello,

I own a Dako that is covered by recall Z-2425-2018 from Dako.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2425-2018 (February 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2425-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

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