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Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: ...

FDA Device Recall #Z-1093-2014 — Class II — January 21, 2014

Recall Summary

Recall Number Z-1093-2014
Classification Class II — Moderate risk
Date Initiated January 21, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dako North America Inc.
Location Carpinteria, CA
Product Type Devices
Quantity 49

Product Description

Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

Reason for Recall

Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.

Distribution Pattern

Worldwide Distribution - USA Nationwide and in the country of Chile.

Lot / Code Information

Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.

Other Recalls from Dako North America Inc.

Recall # Classification Product Date
Z-2425-2018 Class II PD-L1 IHC 22C3 pharmDx is a companion diagnosti... Feb 2, 2018
Z-2099-2016 Class II Dako HER2 CISH pharmDx Kit, product code: SK 10... Jun 10, 2016
Z-0220-2016 Class II EnVision FLEX/HRP visualization reagent found i... Sep 4, 2015
Z-1548-2015 Class II Test Request Distributor (TRD 1.3 and TRD 1.4),... Apr 1, 2015
Z-1261-2015 Class II Autostainer Link 48 (AS480), Autostainer Plus L... Feb 12, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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