Device product
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.
Z-0775-2014
Product summary
- Event
- Event 67065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0775-2014
Official wording
Reason: Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Code information: PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
Distribution pattern: Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
Derived failure modes
-
Unknown
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.