Recall Z-0775-2014— Lab Vision Corporation
Class II · Terminated
Class II FDA medical device recall by Lab Vision Corporation, initiated 2013-12-06, terminated 2014-02-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues..
- Recalling firm
- Lab Vision Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-06
- Terminated
- 2014-02-25
- Firm location
- Fremont, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.