Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
This recall is currently active, issued October 15, 2024. It was issued by Leica Biosystems Nussloch Gmbh Heidelberger Str. 17-19 Nussloch Germany.
- Recall Initiated
- September 4, 2024
- Posted
- October 15, 2024
- Recall Number
- Z-0086-2025
- Quantity
- 13 units
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
a) Material Number 1491510C002, UDI/DI (01)04049188002945, Serial Numbers: 5359022006, 5367012006, 5913, 5996, 5065, 5625022007, 5467072006, 5901, 5108122004, 5330, 5269, 5667; b) Material Number 1491510C003, UDI/DI (01)04049188002891. Serial Numbers: 5537
Root Cause
Labeling design
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