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U.S. Department of Health and Human Services

Class 2 Device Recall Peloris II Rapid Tissue Processor

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 Class 2 Device Recall Peloris II Rapid Tissue Processorsee related information
Date Initiated by FirmApril 11, 2011
Date PostedJune 20, 2011
Recall Status1 Terminated 3 on June 20, 2011
Recall NumberZ-2597-2011
Recall Event ID 58502
Product Classification Automated tissue processor. - Product Code IEO
ProductPeloris 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.
Code Information catalog number 26.0005, serial numbers 0265050B, 0265051B, 0265053B, 0265054B, 0265055B, 0265056B, 0265057B, 0265058B, 0265059B, 0265060B, 0265061B, 0265063B, 0265064B, 0265067B, 0265068B, 0265071B and 0265072B.
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact
800-248-0123
Manufacturer 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 2		Nonconforming Material/Component
ActionLeica 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.
Quantity in Commerce22 units
DistributionWorldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.
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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