FDAFDA · Food and drugs·Recall number Z-0775-2014
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.
Published January 22, 2014 · Recall initiated: December 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lab Vision Corporation
- Distributor
- Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
- Lot
- PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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