Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,
Summary
The FDA issued a Class II for Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148 by LEICA BIOSYSTEMS NUSSLOCH GMBH. Reason: As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flamma.
Details
Source
Device Recall
External ID
Z-0087-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Lot/Code Info: 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: 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, 3508062003, 3421, 3400022003, 4180062004, 3496052003, 3321012003, 5307032007, 5620032008, 1336, 3322012003, 3980, 3276122002, 3306012003, 979021999, 2068022001, 1887092000, 3207, 1031031999, 2968072002, 2788032002, 4231072004, 794101998, 454051999, 5668, 4527022005, 952021999, 1663, 1387121999, 2172, 3760112003, 2936062002, 1076051999, 3558062003, 2939062002, 2906052002, 4264092004, 4471, 3333022003, 2363092001, 3876022004, 2586122001, 3435042003, 4252092004, 2903052002, 5064, 5755, 1856092000, 777101998, 5361, 5607, 2736022002, 2750022002, 917011999, 3689102003, 3197, 2260062001, 4049042004, 4925022006, 1843092000, 5315042007, 4167, 2911082002, 447031998, 2461102001, 3415, 3603082003, 904, 2145022001, 2028122000, 5660052008, 5052, 2861042002, 1321101999, 453, 3008, 3096102002, 2717022002, 3193112002, 3030082002, 961021999, 3202, 1153061999, 475031998, 2782, 5465, 5579, 3631092003, 5030062006, 3168102002, 3251122002, 5141092006, 3927, 2227052001, 757101998, 573051998, 5267, 2707, 3598, 220042001, 4833102005, 3024082002, 2890052002, 4593032005, 2335072001, 5108092006, 3488, 1878062001, 2757032002, 1063041999, 3679, 1310101999, 1561032000, 3647092003, 4466012005, 2798032002, 4159, 5095082006, 4589032005, 3068102002, 2632012002, 1315, 2215042001, 3869022004, 2425092001, 4160052004, 3354022003, 4774, 5001052006, 5740092008, 3445, 4898, 4954032006, 1164071999, 5355062007, 4976042006, 4728062005, 3407032003, 5727, 4588, 5280, 5659, 5814, 4639052005, 416011998, 3316, 3499052003, 1121061999, 5805112008, 2909062002, 5716072008, 4202, 4816, 4355102004, 2780032002, 4228, 2089022001, 1776082001, 2139, 5335, 4861112005, 608051998, 1753, 2735022002, 2599112001, 5393072007, 5813122008, 5531122007, 332111997, 3025, 4608032005; c) Material Number 14901850001R0501, UDI/DI 04049188003423, Serial Numbers: 4723; d) Material Number 1491850UVUL, UDI/DI 04049188002730, Serial Numbers: 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, 1259032008, 1524, 382, 1313052008, 1255032008, 1325, 1017, 1016, 1055102007, 702, 345112005, 1044102007, 1047102007, 1403, 526, 602102006, 455042006, 894, 1320052008
Quantity Affected: 322 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-04
Company
Nussloch
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LEICA BIOSYSTEMS NUSSLOCH GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LEICA BIOSYSTEMS NUSSLOCH GMBH have FDA actions?
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0087-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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