FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: 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.
- Recall number
- Z-3181-2011
- Recalling firm
- Leica Microsystems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-07-26
- Posted
- 2011-09-09
- Terminated
- 2011-09-09
- Reason
- There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
- Root cause
- Employee error
- 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.
- Quantity
- 3 units
- Distribution
- Nationwide Distribution-in the states of Indiana and Kentucky.
- Lot, serial or model codes
- Catalog number PA0535, lot number 13817
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3000210133
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28