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Terminated

Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

FDA Recall Z-3181-2011 · Posted 2011-09-09

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeNJT
Date Initiated2011-07-26
Date Terminated2011-09-09
Product Quantity3 units

Reason for Recall

There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.

Firm Action

Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution-in the states of Indiana and Kentucky.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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