Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog numbe

FDA device recall Z-2597-2011 · posted 2011-06-20 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another,

Action taken

Leica Microsystems sent a MEDICAL DEVICE CORRECTION letter dated April 11, 2011, to the affected customers via first class mail. The letter identified the product, the problem, and the action needed to be taken by the customer. The Customers were instructed to discontinue use of the device until their local Leica Microsystems representative contact them to arrange the replacement of the faulty impellor. The accounts were asked to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IEO

Quantity affected

22 units

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.

Date initiated

2011-04-11

Date posted

2011-06-20

Date terminated

2011-06-20

Location

Bannockburn, IL