FDA Medical Device Recalls (openFDA)
Biogenex Laboratories, Inc.: InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
- Recall number
- Z-2113-2014
- Recalling firm
- Biogenex Laboratories, Inc.
- Product
- InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2014-07-01
- Posted
- 2014-07-24
- Terminated
- 2014-07-24
- Reason
- Product was distributed without 510(k) approval.
- Root cause
- No Marketing Application
- Action
- Each customer contacted by phone - neither is in possession of the product.
- Quantity
- 4 kits
- Distribution
- Brazil and Ecuador. No US distribution
- Lot, serial or model codes
- Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVC
- Firm FEI
- 2936532
- Firm city
- Fremont
- 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