FDA-Device2024-10-23Class II
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
LEICA BIOSYSTEMS NUSSLOCH GMBH
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.
Sold states
US Nationwide distribution.
Affected count
13 units
Manufactured in
Heidelberger Str. 17-19, Nussloch, Germany
Products
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2025Don't want to check this manually?
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