Reported Oct 23, 2024 · Ongoing
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, 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 CM3050 S
- Material Numbers
a) 14047033518b) 14903050S01c) 14903050S02d) 14903050S03for freezing and sectioning tissue samples
- Lot codes and dates
a) Material Number 14047033518UDI/DI 04049188065599
- Serial Numbers
501301200831510520023559082003b) Material Number 14903050S01UDI/DI 04049188003270
- Serial Numbers
157 of 157 codes
364141190120055212102008400210200439440920043137042002368312200351194125022005417103200539540920042636102000384705200443871220054585092006473402200739510920043342112002520808200845750920064521052006252905200026054384102005453806200648074269062005270012200031570520024094012005450304200635640820034654285707200138740620042418022000341701200345720820063349374802200448500720074948102007358809200331360420024415122005445402200632400720025104052008300901200241424014112004242102200033763901072004316305200239170720042781042001422305200543010920055131062008
- Serial Numbers
2624052001480205200726330920003187062002390807200434590320032890082001378336090920032627092000334411200237950420042853072001340110200343934391102005d) Material Number 14903050S03UDI/DI 04049188003188
- Serial Numbers
49260920074644112006300401200252264958451836445070
- Amount recalled
- 187 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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