Z-0114-06

K 520711-2, Hercep Test, 35Test, HER2, Protein

Name: Z-0114-06 K 520711-2, Hercep Test, 35Test, HER2, Protein
Creator: Dakocytomation California Inc
Published: 2005-09-29
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2005-09-29 / Terminated

FDA source

Dakocytomation California Inc began a recall of K 520711-2, Hercep Test, 35Test, HER2, Protein on 2005-09-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0114-06
Status: Terminated
Initiated: 2005-09-29
Posted: 2005-11-01
Terminated: 2007-01-29
Recalling firm: Agilent Technologies, Inc.
Product: K 520711-2, Hercep Test, 35Test, HER2, Protein
Product code: MVC System, Test, Her-2/Neu, Ihc
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.
FDA root cause: Other
Action: Notification letter dated Sept 29,2005 was sent by certified mail to consignees instructing disposal of product.
Quantity in commerce: 420
Distribution: Nationwide
Product codes and lots: Lot number: 00016965, 100018107

Product code MVC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)