Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Cat

FDA device recall Z-3180-2011 · posted 2011-09-09 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

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

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.

Root cause

Employee error

Status

Terminated

Product code

NJT

Quantity affected

1 kit

Distribution

Nationwide Distribution-in the states of Indiana and Kentucky.

Date initiated

2011-07-26

Date posted

2011-09-09

Date terminated

2011-09-09

Location

Buffalo Grove, IL