Company: LEICA BIOSYSTEMS NUSSLOCH GMBH
Date of Enforcement Report: 2/27/2025
Class II
PRODUCT
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Recall Number:
Z-1247-2025
REASON:
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
RECALLING FIRM/MANUFACTURER:
LEICA BIOSYSTEMS NUSSLOCH GMBH
VOLUME OF PRODUCT IN COMMERCE:
2
DISTRIBUTION:
Worldwide – US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.
