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U.S. Department of Health and Human Services

Class 3 Device Recall Leica Bond Aspirating Probe Cleaning System

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  Class 3 Device Recall Leica Bond Aspirating Probe Cleaning System see related information
Date Initiated by Firm July 26, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-3180-2011
Recall Event ID 59677
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom.

The Bond Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probes on Bond-max and Bond-x instruments, using the aspirating probe cleaning protocol installed in Bond systems.
Product Quantity Distributed (Int) 1 kit
Code Information Catalog number CS9100, lot number 13808
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Ms. M. Elizabeth Culotta
847-405-6565
Manufacturer Reason
for Recall		 There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
FDA Determined
Cause 2		 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 in Commerce 1 kit
Distribution Nationwide Distribution-in the states of Indiana and Kentucky.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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