Recall Z-1551-2010 ยท IEO Processor, Tissue, Automated
Leica Microsystems, Inc.
Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005
| Date | May 7, 2010 (initiated Feb 9, 2010) |
| Status | Terminated |
| Reason | Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies. |
| 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 soft |
| Quantity | 574 units |
| Distribution | Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.