Devices

Device Recall Leica Bond ReadytoUse Primary Antibody CD2 (11F11)

Model / Serial
Catalog No. PA0271, lot numbers 08173, 11855 and 14784
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Product Description
Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. PA0271; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. || For the qualitative identification by light microscopy of human CD2 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
Manufacturer
Leica Microsystems, Inc.
1 Event
- Recall of Device Recall Leica Bond ReadytoUse Primary Antibody CD2 (11F11)

Manufacturer

Leica Microsystems, Inc.

Manufacturer Address
Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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