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Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: L...

FDA Recall #Z-0775-2014 — Class II — December 6, 2013

Recall #Z-0775-2014 Date: December 6, 2013 Classification: Class II Status: Terminated

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.

Recalling Firm

Lab Vision Corporation — Fremont, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5

Distribution

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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