Devices

Device Recall InSite

Model / Serial
Lot Numbers: AM134P1005
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
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 Description
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
Manufacturer
Biogenex Laboratories
2 Events
- Recall of Device Recall InSite
- Recall of Device Recall InSite

Manufacturer

Biogenex Laboratories

Manufacturer Address
Biogenex Laboratories, 4600 Norris Canyon Rd, San Ramon CA 94583-1320
Source
USFDA

3 devices with a similar name

Learn more about the data here

Device Recall InSite

Model / Serial
Lot Numbers: RD1340205, RD1340205X, RD1340205Y
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
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 Description
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; || Model Numbers: RD134-60K; || Lot Numbers: RD1340205, RD1340205X, RD1340205Y
Manufacturer
Biogenex Laboratories

Device Recall InSite

Model / Serial
Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
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 Description
Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; || Model Numbers: RD134-YAX; || Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206
Manufacturer
Biogenex Laboratories

Device Recall InSite HER2/neu Detection Kit

Model / Serial
Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Brazil and Ecuador. No US distribution
Product Description
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Manufacturer
Biogenex Laboratories, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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