Class 2 Device Recall HistoCore Arcadia H

• Date Initiated by Firm: May 10, 2024
• Date Posted: August 07, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2529-2024
• Recall Event ID: 94776
• Product Classification: Dispensers, paraffin - Product Code IDW
• Product: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
• Code Information: Model/Catalog Number: 14039354100; UDI-DI: 04049188194763, Serial numbers: 58, 62, 98, 99, 101, 117,120, 121, 122, 123, 124, 125, 127, 128, 129, 177, 178, 179, 180, 181, 185, 186, 218, 222, 223, 279, 282, 284, 286, 287, 288, 289, 290, 291, 292, 314, 315, 317, 318, 319, 321, 322, 353, 354, 355, 356, 357, 358, 360, 363, 365, 366, 371, 478, 480, 483, 484, 487, 488, 489, 490, 491, 492, 553, 560, 561, 562, 584, 586, 588, 589, 590, 593, 597, 643, 644, 647, 649, 650, 651, 652, 653, 656, 658, 659, 697, 698, 705, 710, 714, 715, 716, 717, 739, 740, 741, 742, 743, 757, 819, 820, 821, 822, 825, 826, 827, 828, 829, 830, 831, 832, 878, 879, 880, 881, 882, 883, 884, 885, 886, 887, 888, 889, 890, 891, 892, 893, 894, 896, 897, 898, 900, 901, 904, 906, 907, 909, 911, 919, 921, 922, 923, 924, 927, 928, 930, 1113, 1114, 1115, 1116, 1117, 1118, 1123, 1124, 1198, 1199, 1200, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1212, 1216, 1217, 1266, 1267, 1268, 1271, 1273, 1274, 1277, 1278, 1279, 1280, 1283, and 1285. Model/Catalog Number: 14039357258; UDI-DI: 04049188205971, serial number 5033.
• FEI Number: 3002179321
• Recalling Firm/ Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH ; Heidelberger Str. 17-19; Nussloch Germany
• For Additional Information Contact: Margaret Walczak; 815-2002717
• Manufacturer Reason for Recall: An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
• FDA Determined Cause: Device Design
• Action: The recalling firm issued letters dated 4/30/2024 via email on 5/10/2024. The letter provided the model and serial number of the devices involved, a description of the problem, and immediate actions to be taken. The consignee is to check to see if they have one of the affected instruments and determine whether the Arcadia H is in active use in the facility. If it is, the consignee is to discontinue the use of it immediately and disconnect it from main voltage. If it has not been decommissioned at the time of receipt of the letter, the consignee is to reach out to their sales representative. The sales representative will work with the consignee to determine the disposition of the device according to their local regulations. The consignee is requested to pass the notification letter to users of the device and to all within their organization who need to know. The consignee is to confirm receipt of the letter within 5 days by completing the attached acknowledgement form and returning a scanned copy via email.
• Quantity in Commerce: 180 devices
• Distribution: US Nationwide, including government 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.