FDAJune 10, 2016device
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 chromoso...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
dako north americadakodako north
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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