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U.S. Department of Health and Human Services

Class 2 Device Recall Tissue Processor

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  Class 2 Device Recall Tissue Processor see related information
Date Initiated by Firm June 19, 2017
Create Date July 03, 2017
Recall Status1 Open3, Classified
Recall Number Z-2660-2017
Recall Event ID 77603
Product Classification Processor, tissue, automated - Product Code IEO
Product Nussloch GmbH ASP6025 Tissue Processor
Code Information Serial No. 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 238, 240, 242, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 290, 292, 294, 296, 298, 300, 302, 304, 308, 312, 320, 334, 336, 338, 340, 342, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 378, 380, 382, 384, 386, 388, 396, 400, 402, 406, 408, 418, 420, 422, 424, 426, 428, 432, 434, 438, 440, 442, 444, 450, 452, 454, 456, 460, 462, 464, 468, 478, 480, 482, 484, 486, 488, 490, 492, 498, 502, 504, 516, 526, 530, 536, 544, 546, 548, 550, 554, 556, 558, 560, 562, 564, 570, 572, 574, 576, 580, 582, 584, 586, 588, 590, 598, 604, 612, 614, 628, 632, 636, 640, 642, 646, 650, 654, 660, 662, 666, 668, 674, 676, 684, 686, 692, 694, 696, 698, 700, 702, 704, 706, 712, 718, 720, 726, 728, 730, 732, 734, 736, 738, 742, 744, 746, 770, 784, 794, 796, 808, 810, 814, 816, 818, 820, 824, 834, 858, 860, 864, 866, 868, 870, 874, 878, 886, 892, 314, 316, 448, 538, 594, 622, 712, 778.
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact
800-225-8867
Manufacturer Reason
for Recall		 Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.
FDA Determined
Cause 2		 Labeling mix-ups
Action Customers were notified via email on 06/19/2017. Instructions to customers included to clean surface around the Alarm Connectors and place the newly provided label at the Alarm Connectors (over the engraved specification). They were also instructed to update their current Instructions For Use and update the online help function in the software, as well as return the response form.
Quantity in Commerce 812 units
Distribution Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.
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.
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