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Terminated

Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor 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.

FDA Recall Z-2099-2016 · Posted None

Recalling FirmDako North America Inc.
Recall StatusTerminated
Product CodeNYQ
Date Initiated2016-06-10
Date Terminated2016-09-02
Product Quantity31 kits

Reason for Recall

An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.

Firm Action

Dako sent a recall notification dated June 10, 2016 to all customers. The letter identified the affected product, problem, the investigation findings, the affected results, and the actions to be taken. Customers are instructed to complete and return the enclosed device recall form to Dako QA Vigilance by [email protected]. Customers with questions regarding the notification, are instructed to contact their sales representative.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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