Z-2113-2014Class II

InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use

Name: Z-2113-2014 InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use
Creator: Biogenex Laboratories, Inc.
Published: 2014-07-01
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2014-07-01 / Terminated

FDA source

Biogenex Laboratories, Inc. began a recall of InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use on 2014-07-01. FDA classified it as Class II and gives the reason as "Product was distributed without 510(k) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2113-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-01
Posted: 2014-07-24
Terminated: 2014-07-24
Recalling firm: Biogenex Laboratories, Inc.
Product: InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Product code: MVC System, Test, Her-2/Neu, Ihc
Reason for recall: Product was distributed without 510(k) approval.
FDA root cause: No Marketing Application
Action: Each customer contacted by phone - neither is in possession of the product.
Quantity in commerce: 4 kits
Distribution: Brazil and Ecuador. No US distribution
Product codes and lots: Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2113-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2113-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-24

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)