Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491
FDA device recall Z-0088-2025 · posted 2024-10-15 · Open, Classified
Recall details
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- 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.
- Action taken
- Leica Biosystems issued an Urgent Field Action Notice to its consignees on 09/05/2024 via mail. The notice explained the problem with the device and requested the placement of a warning sticker regarding the use of flammable freezing sprays on the device and the addition of a supplemental sheet to the current IFU. For questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, heather.jensen@leicabiosystems.com
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- IDP
- Quantity affected
- 25 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-09-04
- Date posted
- 2024-10-15
- Location
- Nussloch, Germany
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