Home / Recalls / Dako North America Inc. / Z-2425-2018

Z-2425-2018 Class II Terminated

Recalled by Dako North America Inc. — Carpinteria, CA

Recall Details

Product Type
Devices
Report Date
July 18, 2018
Initiation Date
February 2, 2018
Termination Date
November 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1051 kits

Product Description

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

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.

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

Code Information

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

Other recalls by Dako North America Inc.

  • Z-2099-2016 Class II — Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro (June 10, 2016)
  • Z-0220-2016 Class II — EnVision FLEX/HRP visualization reagent found in the following kits: EnVision F (September 4, 2015)
  • Z-1548-2015 Class II — Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Da (April 1, 2015)
  • Z-1261-2015 Class II — Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostain (February 12, 2015)
  • Z-2708-2014 Class II — Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 (August 29, 2014)
  • Z-1093-2014 Class II — Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 (January 21, 2014)
  • Z-0287-2013 Class II — PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automat (May 1, 2008)