Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 5, 2014
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 si
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Dako North America Inc. recalled Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product… — a moderate-severity action.
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product… was recalled by Dako North America Inc. in March 5, 2014. Reason: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.. Check the official notice for the remedy. Verify recall #Z-1093-2014 with the FDA Devices before acting.
The recall
Dako North America Inc. issued this moderate-severity FDA Devices recall — Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed..
- Moderate
- severity level
- 49 units
- affected scope
- Class II
- classification
- March 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1093-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1093-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on January 21, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Dako North America Inc. is listed as the recalling firm, operating out of Carpinteria, CA. Federal records list the affected scope as 49.
The documented reason for this recall is: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and in the country of Chile.. Distribution scope 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. 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.
Affected scope
49
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1093-2014 |
| Date reported | March 5, 2014 |
| Date initiated | January 21, 2014 |
| Recalling firm | Dako North America Inc. |
| Firm location | Carpinteria, CA |
| Affected scope | 49 |
| Distribution | Worldwide Distribution - USA Nationwide and in the country of Chile. |
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-1093-2014) 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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dako North America Inc.. Units affected: 49.
Why was this product recalled? ▼
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1093-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide and in the country of Chile..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1093-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 5, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.