Z-0087-2025 Class II Ongoing

Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples

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.

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