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Recall Observatory FDA recall evidence

Device product

Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.

Z-1704-2016

March 22, 2016

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 73823
Status
Terminated
Classification
Class II
Quantity
290 units
Official record key
device-enforcement:Z-1704-2016

Official wording

Reason: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

Code information: Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.

Distribution pattern: Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.