FDA Enforcement
Class II
Terminated
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Recall: Z-0775-2014
·
Reported January 22, 2014
Enforcement
- Recall Number
- Z-0775-2014
- Event ID
- 67065
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Lab Vision Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2014
- Initiation Date
- December 6, 2013
- Classification Date
- January 16, 2014
- Termination Date
- February 25, 2014
- Address
- 46117 Landing Pkwy, Fremont, CA, 94538-6407, United States
Description
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Reason
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Code Info
PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
Distribution
Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
Quantity
5