Brand Name: Leica Biosystems Cryostats Product Name recall: Software Issue
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Why was Brand Name: Leica Biosystems Cryostats Product Name recalled?
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
- Product
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Quantity
- 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.
- Recall date
- March 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)