Z-0609-06

Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered...

Name: Z-0609-06 Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered...
Creator: Biogenex Laboratories
Published: 2006-02-09
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2006-02-09 / Terminated

FDA source

Biogenex Laboratories began a recall of Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody... on 2006-02-09. The reason FDA records is "Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0609-06
Status: Terminated
Initiated: 2006-02-09
Posted: 2006-03-15
Terminated: 2006-08-23
Recalling firm: Biogenex Laboratories, Inc.
Product: Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; Model number: AM134-10MP; Lot Numbers: AM134P1005
Product code: MVC System, Test, Her-2/Neu, Ihc
Reason for recall: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
FDA root cause: Other
Action: On 2/9/06, the firm issued letters via UPS to all of its consignees, informing them of the affected products and providing instructions on the recall.
Quantity in commerce: 1 unit
Distribution: Nationwide. Italy, and United Kingdom. The product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI. One VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073. 2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom
Product codes and lots: Lot Numbers: AM134P1005

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)