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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67380

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 21, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dako North America Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1093-2014
Recall number
Z-1093-2014
Initiated
January 21, 2014
Classification
Class II
Status
Terminated
Recalling firm
Dako North America Inc.
Quantity
49

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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