FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: 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.
- Recall number
- Z-2597-2011
- Recalling firm
- Leica Microsystems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-04-11
- Posted
- 2011-06-20
- Terminated
- 2011-06-20
- Reason
- The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another,
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 22 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Australia, Canada, Germany Japan, Portugal and United Kingdom.
- Lot, serial or model codes
- catalog number 26.0005, serial numbers 0265050B, 0265051B, 0265053B, 0265054B, 0265055B, 0265056B, 0265057B, 0265058B, 0265059B, 0265060B, 0265061B, 0265063B, 0265064B, 0265067B, 0265068B, 0265071B and 0265072B.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IEO
- Firm FEI
- 3000210133
- Firm city
- Bannockburn
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28