Dakocytomation California Inc K 520411-2, Hercep Test, 35Test, HER2, Protein Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
K 520411-2, Hercep Test, 35Test, HER2, Protein
Brand
Dakocytomation California Inc
Lot Codes / Batch Numbers
Lot number: 00016943
Products Sold
Lot number: 00016943
Dakocytomation California Inc is recalling K 520411-2, Hercep Test, 35Test, HER2, Protein due to Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene G. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026