Recall Z-0114-06 ยท MVC System, Test, Her-2/Neu, Ihc
Dakocytomation California Inc
K 520711-2, Hercep Test, 35Test, HER2, Protein
| Date | Nov 1, 2005 (initiated Sep 29, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product. |
| Quantity | 420 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.