FDA Devices recall · Reported July 6, 2016
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
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.
Dako North America Inc. recalled Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnost… - a moderate-severity action.
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnost… was recalled by Dako North America Inc. in July 6, 2016. Reason: An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. T…. Check the official notice for the remedy. Verify recall #Z-2099-2016 with the FDA Devices before acting.
The recall
Dako North America Inc. issued this moderate-severity FDA Devices recall-An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. T….
- Moderate
- severity level
- Class II
- classification
- July 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2099-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2099-2016 |
| Date reported | July 6, 2016 |
| Date initiated | June 10, 2016 |
| Recalling firm | Dako North America Inc. |
| Firm location | Carpinteria, CA |
| Affected scope | 31 kits |
| Distribution | 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, Se… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2099-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026