Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

Code information: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

Distribution pattern: 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.