RecallDepth

Nussloch GmbH ASP6025 Tissue Processor

Company
Leica Microsystems, Inc.
Recall Initiated
June 19, 2017
Recall Number
Z-2660-2017
Quantity
812 units
Firm Location
Buffalo Grove, IL

Reason for Recall

Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

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.

Lot / Code Info

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.

Root Cause

Labeling mix-ups

Action Taken

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.

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