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LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149
Recalled October 23, 2024 · FDA recall Z-0088-2025 · LEICA BIOSYSTEMS NUSSLOCH
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. · FDA Class II
Units
25 units
Sold at
US Nationwide distribution.
Description
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.
Product
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
Manufacturer(s)
LEICA BIOSYSTEMS NUSSLOCH GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →