Recall Z-0085-2025— LEICA BIOSYSTEMS NUSSLOCH GMBH
Class II · Ongoing
Class II FDA medical device recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, initiated 2024-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples. 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..
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-04
- Firm location
- Nussloch, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.