Class 2 Device Recall Leica

• Date Initiated by Firm: September 04, 2024
• Date Posted: October 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0087-2025
• Recall Event ID: 95323
• Product Classification: Microtome, cryostat - Product Code IDP
• Product: Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
• Code Information: 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
• FEI Number: 3002179321
• Recalling Firm/ Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH; Heidelberger Str. 17-19; Nussloch Germany
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• Action: Leica Biosystems issued an Urgent Field Action Notice to its consignees on 09/05/2024 via mail. The notice explained the problem with the device and requested the placement of a warning sticker regarding the use of flammable freezing sprays on the device and the addition of a supplemental sheet to the current IFU. For questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, heather.jensen@leicabiosystems.com
• Quantity in Commerce: 322 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.