{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210084", "product_res_number": "Z-0087-2025", "event_date_initiated": "2024-09-04", "event_date_posted": "2024-10-15", "recall_status": "Open, Classified", "res_event_number": "95323", "product_code": "IDP", "product_description": "Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, \nb) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples", "code_info": "a) Material Number 14047131148, UDI/DI 04049188064790, Serial Numbers: 598061998, 1874062001, 329111997, 370121997, 175081997, 517041998, 376021998, 702071998, 2935062002, 333041998, 693071998, 3524062003; \nb) 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; \nc) Material Number 14901850001R0501, UDI/DI 04049188003423, Serial Numbers: 4723; \nd) 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", "firm_fei_number": "3002179321", "recalling_firm": "LEICA BIOSYSTEMS NUSSLOCH GMBH", "address_1": "Heidelberger Str. 17-19 17-19 heidelberger str.", "city": "Nussloch", "country": "Germany", "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.", "root_cause_description": "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. \nFor questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, heather.jensen@leicabiosystems.com", "product_quantity": "322 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "registration_number": [ "8010478", "3010781643", "3021013124", "3003584784", "3006610913", "3005642384", "3043606682", "3015167933", "3008399755", "3002821232", "1063851", "2083544", "3043088937", "3043138885", "3038188821", "9615162", "3014680809", "1000391282", "3004594181", "3027645317", "3010889707" ], "fei_number": [ "3010781643", "3021013124", "3003584784", "3006610913", "3002179321", "3005642384", "3043606682", "3015167933", "3008399755", "3002821232", "2083544", "3043088937", "3004063640", "3043138885", "3038188821", "3014680809", "1000391282", "3004594181", "1000442352", "3027645317", "3010889707" ], "k_number": [ "K883514" ], "device_name": "Microtome, Cryostat", "medical_specialty_description": "Pathology", "regulation_number": "864.3010", "device_class": "1" } } ] }