Food, drugs, devices › Dako North America Inc.
Device recall: Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use
FDA enforcement event 67380 is a device recall by Dako North America Inc. of Carpinteria, CA, initiated 21 Jan 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 4 Jun 2014. Initiation: voluntary: firm initiated. Dako North America Inc. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Dako North America Inc., Carpinteria, CA.
Reason for recall
"Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed."
Distribution
"Worldwide Distribution - USA Nationwide and in the country of Chile."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1093-2014 | 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… | 49 | Class II | Terminated | 5 Mar 2014 |
Context
Other enforcement events for Dako North America Inc.
All 8 events for Dako North America Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA Nationwide and in the country of Chile."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.