Leica Biosystems Melbourne Pty Ltd

FDA Regulatory Profile

Leica Biosystems Melbourne Pty Ltd appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1683-2025, Class II) was initiated on April 2, 2025.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1683-2025Class IIHistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HiApril 2, 2025