Reported Jan 22, 2014 · Terminated

Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation,…

Lab Vision Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lab Vision Corporation · 46117 Landing Pkwy · Fremont, CA · 94538-6407

Is this the product you have?

  • Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg
  • ml) Manufactured byLab 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
Lot codes and dates
    • PN/ MS-354-P0
    • LN 354P1206K
    • Expiration 03/2015
Amount recalled
5

Where it was sold

Why it was recalled

Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 25, 2014 · Data as of Sep 19, 6:01 PM UTC

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