K 520411-2, Hercep Test, 35Test, HER2, Protein
FDA device recall Z-0113-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Dakocytomation California Inc
- 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.
- Action taken
- Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MVC
- Quantity affected
- 545
- Distribution
- Nationwide
- Date initiated
- 2005-09-29
- Date posted
- 2005-11-01
- Date terminated
- 2007-01-29
- Location
- Carpinteria, CA
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