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Terminated

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

FDA Recall Z-3180-2011 · Posted 2011-09-09

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeNJT
Date Initiated2011-07-26
Date Terminated2011-09-09
Product Quantity1 kit

Reason for Recall

There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution-in the states of Indiana and Kentucky.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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