Reported Oct 23, 2024 · Ongoing
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,…
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 CM1850
- Material Numbers
a) 14047131148b) 14901850001c) 14901850001R0501d) 1491850UVULfor freezing and sectioning tissue samples
- Lot codes and dates
a) Material Number 14047131148UDI/DI 04049188064790
- Serial Numbers
598061998187406200132911199737012199717508199751704199837602199870207199829350620023330419986930719983524062003b) Material Number 14901850001UDI/DI 04049188003423
- Serial Numbers
232 of 232 codes
1922112000239608200120321220001850092000372818853156102002344103200316840820013682102003308010200247911439351706200311860719995742397602200421709199796002199920970220014660052005310728053425032003188409200072910199814071219991678062000287005200233460220031716062000322211200221440420014211072004154203200030691020024690219984955032006567405200828730520029151219982812042002174207200047205508494703200641370520043318012003335703200345480320051110061999472206200547215507292541290420042628122001250910200121360420014118
- Serial Numbers
4723d) Material Number 1491850UVULUDI/DI 04049188002730
- Serial Numbers
79 of 79 codes
2160520054827650120073321067118701200812084175110720061095102007134712009700820073708954940620064540820068700520071488672122006114912200710591345658122006119601200830109200577201200770801200770901200765511200680202200786805200788569812200651307200637814539910820072010520051076102007138999761026508200567112200689611374290320061317052008949987082007189646112006597130704200811281120077920220077715760920061272
- Amount recalled
- 322 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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