Z-2425-2018Class II

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

Name: Z-2425-2018 PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient...
Creator: Dako North America Inc.
Published: 2018-02-02
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2018-02-02 / Terminated / root cause: manufacturing process

FDA source

Dako North America Inc. began a recall of PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options on 2018-02-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2425-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-02
Posted: 2018-07-11
Terminated: 2020-11-10
Recalling firm: Agilent Technologies, Inc.
Product: PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Product code: PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 2, 2018 the firm sent letters to the consignees with the following instructions; Description of the issue: The Field Correction has been initiated to correct the kit's Instructions for Use (I FU) as the storage time for Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma cut sections will be changed from six months to five months. This means that section 8.2: Cut Section Storage Recommendation will be changed to the following: 'To preserve antigenicity, tissue sections, once mounted on slides, should be held in the dark at 2-8 C (preferred), or at room temperature up to 25 C. Slide storage and handling conditions should not exceed 25 C at any point post-mounting to ensure tissue integrity and antigenicity. 8.2.1 NSCLC Cut Section Storage Recommendation Cut sections must be stained within 6 months when stored at 2-8 C (preferred), or at 25 C. 8.2.2 Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Cut Section Storage Recommendation Cut sections must be stained within 5 months when stored at 2-8 C (preferred), or at 25 C." Note that only Gastric and Gastroesophageal Junction (GEJl Adenocarcinoma cut section storage time has been updated. Storage time for Non-Small Cell Lung Cancer (NSCLCl cut sections remains the ~ You may continue the use of PD-Ll IHC 22C3 pharmDx, Code No. SK006. However, we recommend that your laboratory follow the instructions noted to preseive the antigenicity, as this may decrease after five months of cut section storage. Potential patient risk: Based on our investigations, there is a remote possibility that staining Gastric and Gastroesophageal (GEJ) Adenocarcinoma cut sections may result in a weak staining or a false negative staining after five months of storage. However, there have been no reported incidents based on the previous storage time recommendation. Actions to be taken by the user: Within 10 calendar days, please take the following actions 1. Discard the IFU provided within the PD-Ll
Quantity in commerce: 1051 kits
Distribution: 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
Product codes and lots: Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2425-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2425-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-11

Product code PLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)