Z-1551-2010

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

Name: Z-1551-2010 Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia...
Creator: Leica Microsystems, Inc.
Published: 2010-02-09
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2010-02-09 / Terminated

FDA source

Leica Microsystems, Inc. began a recall of Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005 on 2010-02-09. The reason FDA records is "Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1551-2010
Status: Terminated
Initiated: 2010-02-09
Posted: 2010-05-07
Terminated: 2011-06-30
Recalling firm: Leica Microsystems, Inc.
Product: Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005
Product code: IEO Processor, Tissue, Automated
Reason for recall: Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies.
FDA root cause: Other
Action: Leica Microsystems sent Medical Device Correction letters dated 2/9/10 to the affected customers via first class mail on the same date, informing them of the potential for tissue damage during processing and outlining the software upgrade being made to minimize the risk of tissue damage. Customers were informed that their local Leica Microsystems representative will contact them to arrange the software upgrade and to provide training on the use of the new software. The letters also provided the necessary steps required to avoid tissue damage during processing while they are awaiting the software upgrade. 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.
Quantity in commerce: 574 units
Distribution: Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia.
Product codes and lots: catalog number 26.0001 and 26.0005, serial numbers 0260001B to 0260341B, 0260344B, 0260346B to 0260353B, and 0260356B to 0260366B.

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)