Leica HistoCore Arcadia H recall
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Why was Leica HistoCore Arcadia H recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Quantity
- 180 devices
- Distribution
- US Nationwide, including government distribution.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)