Recall Z-2597-2011
Leica Microsystems, Inc. · initiated April 11, 2011
Product
Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0005. This tissue processor prepares tissue samples for sectioning by transforming fixed samples into wax embedded samples. This is achieved by exposing the tissue samples to a sequence of reagents in the processing retorts.
Codes / lots: catalog number 26.0005, serial numbers 0265050B, 0265051B, 0265053B, 0265054B, 0265055B, 0265056B, 0265057B, 0265058B, 0265059B, 0265060B, 0265061B, 0265063B, 0265064B, 0265067B, 0265068B, 0265071B and 0265072B.
Reason for recall
The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another,
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2597-2011
- Initiated
- April 11, 2011
- Posted by FDA
- June 20, 2011
- Terminated
- June 20, 2011
- Product code
- IEO – Processor, Tissue, Automated
- Quantity
- 22 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.
- Recalling firm
- Leica Microsystems, Inc., Bannockburn, IL