Devices

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.
1 Event
- Recall of Device Recall InSite HER2/neu Detection Kit

Manufacturer

Biogenex Laboratories, Inc.

Manufacturer Address
Biogenex Laboratories, Inc., 49026 Milmont Dr, Fremont CA 94538-7301
Source
USFDA

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