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) 14047131148
    • b) 14901850001
    • c) 14901850001R0501
    • d) 1491850UVUL
    • for freezing and sectioning tissue samples
Lot codes and dates
    • a) Material Number 14047131148
    • UDI/DI 04049188064790
  • Serial Numbers
    • 598061998
    • 1874062001
    • 329111997
    • 370121997
    • 175081997
    • 517041998
    • 376021998
    • 702071998
    • 2935062002
    • 333041998
    • 693071998
    • 3524062003
    • b) Material Number 14901850001
    • UDI/DI 04049188003423
  • Serial Numbers

    232 of 232 codes

    • 1922112000
    • 2396082001
    • 2032122000
    • 1850092000
    • 3728
    • 1885
    • 3156102002
    • 3441032003
    • 1684082001
    • 3682102003
    • 3080102002
    • 4791
    • 1439
    • 3517062003
    • 1186071999
    • 5742
    • 3976022004
    • 217091997
    • 960021999
    • 2097022001
    • 4660052005
    • 3107
    • 2805
    • 3425032003
    • 1884092000
    • 729101998
    • 1407121999
    • 1678062000
    • 2870052002
    • 3346022003
    • 1716062000
    • 3222112002
    • 2144042001
    • 4211072004
    • 1542032000
    • 3069102002
    • 469021998
    • 4955032006
    • 5674052008
    • 2873052002
    • 915121998
    • 2812042002
    • 1742072000
    • 4720
    • 5508
    • 4947032006
    • 4137052004
    • 3318012003
    • 3357032003
    • 4548032005
    • 1110061999
    • 4722062005
    • 4721
    • 5507
    • 2925
    • 4129042004
    • 2628122001
    • 2509102001
    • 2136042001
    • 4118
  • Serial Numbers
    • 4723
    • d) Material Number 1491850UVUL
    • UDI/DI 04049188002730
  • Serial Numbers

    79 of 79 codes

    • 216052005
    • 482
    • 765012007
    • 332
    • 1067
    • 1187012008
    • 1208
    • 417
    • 511072006
    • 1095102007
    • 1347
    • 1200
    • 970082007
    • 370
    • 895
    • 494062006
    • 454082006
    • 870052007
    • 1488
    • 672122006
    • 1149122007
    • 1059
    • 1345
    • 658122006
    • 1196012008
    • 301092005
    • 772012007
    • 708012007
    • 709012007
    • 655112006
    • 802022007
    • 868052007
    • 885
    • 698122006
    • 513072006
    • 378
    • 1453
    • 991082007
    • 201052005
    • 1076102007
    • 1389
    • 997
    • 610
    • 265082005
    • 671122006
    • 896
    • 1137
    • 429032006
    • 1317052008
    • 949
    • 987082007
    • 189
    • 646112006
    • 597
    • 1307042008
    • 1128112007
    • 792022007
    • 771
    • 576092006
    • 1272
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.