Dakocytomation California Inc Recalls

FDA
2
Total Recalls
1
Agencies
Jan 2007
First Recall
Jan 2007
Latest Recall
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Showing 1-2 of 2 recalls

FDA

K 520411-2, Hercep Test, 35Test, HER2, Protein

Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.

Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
FDA

EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000

This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.

Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.