FDA Medical Device Recalls (openFDA)
Dakocytomation California Inc: K 520711-2, Hercep Test, 35Test, HER2, Protein
- Recall number
- Z-0114-06
- Recalling firm
- Dakocytomation California Inc
- Product
- K 520711-2, Hercep Test, 35Test, HER2, Protein
- Status
- Terminated
- Initiated
- 2005-09-29
- Posted
- 2005-11-01
- Terminated
- 2007-01-29
- 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
- Lot, serial or model codes
- Lot number: 00016965, 100018107
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVC
- Firm FEI
- 2022180
- Firm city
- Carpinteria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28