FDAFDA · Food and drugs·Recall number Z-0085-2025
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Published October 23, 2024 · Recall initiated: September 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI 04049188066237, Serial Number 990
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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