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U.S. Department of Health and Human Services

Class 2 Device Recall BOND

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  Class 2 Device Recall BOND see related information
Date Initiated by Firm July 30, 2021
Create Date September 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-2481-2021
Recall Event ID 88453
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Code Information Product Code PA0375, Lot 69909
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact
800-225-8867
Manufacturer Reason
for Recall		 Product may not perform as specified in IFU.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm notified their consignees by email on 07/30/2021. The notice explained the issue and requested destruction of the product.
Quantity in Commerce 237 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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