Home / Recalls / Leica Microsystems, Inc. / Z-2660-2017

Z-2660-2017 Class II Ongoing

Recalled by Leica Microsystems, Inc. — Buffalo Grove, IL

FDA device recall Z-2660-2017 was initiated by Leica Microsystems, Inc. on June 19, 2017 and is designated Class II. Reason for recall: Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. The recall status is ongoing. Affected quantity: 812 units.

Recall Details

Product Type
Devices
Report Date
July 12, 2017
Initiation Date
June 19, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
812 units

Product Description

Nussloch GmbH ASP6025 Tissue Processor

Reason for Recall

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

Distribution Pattern

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.

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.

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  • Z-1851-2022 Class II — Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 104 (August 26, 2022)
  • Z-1848-2022 Class II — Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 (August 26, 2022)
  • Z-0412-2022 Class II — Leica Microsystems M220 F12 Microscope Systems (November 3, 2021)
  • Z-2481-2021 Class II — BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 (July 30, 2021)
  • Z-2399-2020 Class II — Leica ARveo and M530 OH6 microscope systems. (May 20, 2020)

FDA data resources