FDA recall Z-0085-2025

LEICA BIOSYSTEMS NUSSLOCH GMBH · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-09-04
Report date
2024-10-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nussloch, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2025