Reported Oct 23, 2024 · Ongoing
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d)…
Leica Biosystems Nussloch GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEICA BIOSYSTEMS NUSSLOCH GMBH · Heidelberger Str. 17-19 · Nussloch · N/A
Is this the product you have?
- Leica Biosystems Cryostat Model Number CM1900
- Material Numbers
a) 14045227382b) 14901900100c) 14901900700d) 1491900UVU2for freezing and sectioning tissue samples
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 04049188075840Material Number 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996 2 04049188003324Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698 3 04049188003300Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002 4 04049188002570Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006 - Amount recalled
- 25 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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