Recall Z-0609-06 ยท MVC System, Test, Her-2/Neu, Ihc
Biogenex Laboratories
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
| Date | Mar 15, 2006 (initiated Feb 9, 2006) |
| Status | Terminated |
| Reason | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.