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Recall Observatory FDA recall evidence

Device product

Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

Z-0085-2025

September 04, 2024

Class II

Product summary

Firm
LEICA BIOSYSTEMS NUSSLOCH GMBH
Event
Event 95323
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0085-2025

Official wording

Reason: 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.

Code information: UDI/DI 04049188066237, Serial Number 990

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.