Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Reason for Recall:
- Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Product Codes/Lot Numbers:
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1247-2025
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As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.