Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max 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.
This recall has been terminated (originally issued September 9, 2011).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- July 26, 2011
- Posted
- September 9, 2011
- Terminated
- September 9, 2011
- Recall Number
- Z-3182-2011
- Quantity
- 3 units
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
Distribution
Nationwide Distribution-in the states of Indiana and Kentucky.
Lot / Code Info
Catalog number PA0035, lot number 13622
Root Cause
Employee error
Action Taken
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.
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