K 520411-2, Hercep Test, 35Test, HER2, Protein
FDA Recall Z-0113-06 · Posted 2005-11-01
Recalling FirmDakocytomation California Inc
Recall StatusTerminated
Product CodeMVC
Date Initiated2005-09-29
Date Terminated2007-01-29
Product Quantity545
Reason for Recall
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.
Firm Action
Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.