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Recall Observatory FDA recall evidence

Device product

Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

Z-1876-2016

April 05, 2016

Class II

Product summary

Firm
Leica Microsystems, Inc.
Event
Event 73802
Status
Terminated
Classification
Class II
Quantity
270 units
Official record key
device-enforcement:Z-1876-2016

Official wording

Reason: Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

Code information: 1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.

Distribution pattern: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

Field note

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