Recall Z-1683-2025 ยท IEO Processor, Tissue, Automated
Leica Biosystems Melbourne Pty Ltd
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
| Date | Apr 28, 2025 (initiated Apr 2, 2025) |
| Status | Open, Classified |
| Reason | There is a leakage issue associated with the tubing in the manifold of the instrument. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 3/31/25 was sent to customers. ACTIONS REQUIRED 1. If leakage from the instrument is observed in the drip tray or surrounding the instrument, please follow your laboratory's leakage containment/safety protocol. If a protocol is running, wait for the run to finish, switch off the instrument and contact your local Leica Biosystems representative immediately. 2. If no leakage has been observed from the instrument, continue using it as normal. Conduct routine monitoring for leakage until the on-site inspection is completed. 3. Your local L |
| Quantity | 77 units |
| Distribution | US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.