K 520711-2, Hercep Test, 35Test, HER2, Protein
This recall has been terminated (originally issued November 1, 2005).
- Company
- Dakocytomation California Inc
- Recall Initiated
- September 29, 2005
- Posted
- November 1, 2005
- Terminated
- January 29, 2007
- Recall Number
- Z-0114-06
- Quantity
- 420
- Firm Location
- Carpinteria, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot number: 00016965, 100018107
Root Cause
Other
Action Taken
Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
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