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U.S. Department of Health and Human Services

Class 2 Device Recall Peloris Rapid Tissue Processor

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 Class 2 Device Recall Peloris Rapid Tissue Processorsee related information
Date Initiated by FirmFebruary 09, 2010
Date PostedMay 07, 2010
Recall Status1 Terminated 3 on June 30, 2011
Recall NumberZ-1551-2010
Recall Event ID 54566
Product Classification Processor, tissue, automated - Product Code IEO
ProductPeloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005
Code Information catalog number 26.0001 and 26.0005, serial numbers 0260001B to 0260341B, 0260344B, 0260346B to 0260353B, and 0260356B to 0260366B.
FEI Number 3000210133
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact
847-405-6565
Manufacturer 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 Determined
Cause 2		Other
ActionLeica 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 Commerce574 units
DistributionWorldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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