Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Reported: October 23, 2024 Initiated: September 4, 2024 #Z-0085-2025
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.
Details
- Recalling Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution.
- Location
- Nussloch
Frequently Asked Questions
What product was recalled? ▼
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples. Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH. Units affected: 1 unit.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0085-2025.
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