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
This recall has been terminated (originally issued September 9, 2011).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- July 26, 2011
- Posted
- September 9, 2011
- Terminated
- September 9, 2011
- Recall Number
- Z-3180-2011
- Quantity
- 1 kit
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
Distribution
Nationwide Distribution-in the states of Indiana and Kentucky.
Lot / Code Info
Catalog number CS9100, lot number 13808
Root Cause
Employee error
Action Taken
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.
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