Reported Apr 1, 2015 · Terminated

Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product…

Leica Microsystems, Inc.

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: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622

Is this the product you have?

  • Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining
  • Product UsageNCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist
Lot codes and dates
  • Product CodeNCL-L-CD15
  • Lot Numbers and Expiration Dates
    • Lot 6022274
    • Expiry 2015-04
    • Lot 6024628
    • Expiry 2015-08
    • Lot 6030581
    • Expiry 2016-07
Amount recalled
309 units

Where it was sold

Why it was recalled

The staining intensity decreases over the shelf life.

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 Sep 5, 2017 · Data as of Sep 19, 5:31 PM UTC

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