Z-0775-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2014
- Initiation Date
- December 6, 2013
- Termination Date
- February 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product 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 for Recall
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Distribution Pattern
Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
Code Information
PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.