CLASS II Device recall · Reported 18 Jul 2018 · FDA Enforcement Report

PD-L1 IHC 22C3 pharmDx is a companion diagnostic used recalled

Dako North America is recalling PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for, distributed in 29 states. The recall was initiated on 2 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199

Quantity recalled1051 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2425-2018
FDA event ID: 79602
Recalling firm: Dako North America, Carpinteria, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Feb 2018
FDA classified: 11 Jul 2018
Reported: 18 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

2 Feb 2018	Recall initiated by company
11 Jul 2018	Classified by FDA	+159 days
18 Jul 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri New Hampshire New Jersey Nevada

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Dako North America

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Reported	Class	Recall	Company	Reason	Where
6 Jul 2016Device	CLASS II	Dako HER2 CISH pharmDx Kit, product recalled by Dako North America	Dako North America	Other	Nationwide
11 Nov 2015Device	CLASS II	EnVision Flex/Hrp visualization reagent found recalled	Dako North America	Device Malfunction	Nationwide
6 May 2015Device	CLASS II	Test Request Distributor (TRD 1.3 and TRD 1.4) recalled	Dako North America	Device Malfunction	Nationwide
18 Mar 2015Device	CLASS II	Autostainer Plus Link Instrument (AS100) recalled by Dako North America	Dako North America	Packaging Defects	Nationwide
1 Oct 2014Device	CLASS II	Dako Autostainer Link recalled by Dako North America	Dako North America	Device Malfunction	Nationwide

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