Recall of Device Recall Leica Biosystems Richmond Inc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Biosystems Richmond Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74245
  • Event Risk Class
    Class 3
  • Event Number
    Z-2039-2016
  • Event Initiated Date
    2016-05-02
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-12-13
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    automated cell-locating device - Product Code JOY
  • Reason
    Systems have an improperly activated windows 7 os, even though a valid windows 7 license was associated with each manufactured system. the system appears to be unlicensed. these systems cannot be re-activated using standard windows licensing procedures and are requiring checks of each potentially affected system to confirm windows 7 os is properly activated.
  • Action
    Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 2, 2016. According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. The Medical Device Field Correction letter describes the issues identified with the CytoVision Image Analysis and Capture System and the Windows 7 operating system. The letter provided the customer with actions they are required to take which include the following: 1) whether they have a properly activated Windows 7 operating system. 2) If they do not have a properly activated operating system they should to contact Leica Technical Support for additional information and to request a service appointment for correction to their system. For USA customers, they ask that they call 18005374669. International customers are asked to go to http://www.leicabiosystems.com/contactus/contactusonline/ and then choose your country. 3) Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to RichRA@leicamicrosystems.com or faxing it back to us at 18472363800. Service personnel will be sent to the affected customer locations to replace the hard drives of the affected systems.

Device

  • Model / Serial
    System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number 200994, System 23CAP001KFX001 with Serial Number 200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System 23CAP007FXX001 with Serial Number 200930, System 23CAP002KFX001 with Serial Number 201000, System 23CAP001KXX001 with Serial Number 200969, System 23CAP001KFX001 with Serial Number 200942, System 23GSL120KFX001 with Serial Number 200910, System 23CAP001FXX001 with Serial Number 200710, System 23GSLXXXKFXUPG with Serial Number 200890, System 23GSL120KFX001 with Serial Number 201001System 23CAP002FXX001 with Serial Number 200889, System 23GSLXXXKFXUPG with Serial Number 201087, System 23CUP003CVX720 with Serial Number 201086, System 23GSL10XKXX001 with Serial Number 201085, System 23REV001XXX001 with Serial Number 201084, System 23REV001XXX001 with Serial Number 201083, System 23REV001XXX001 with Serial Number 201082, System 23REV001XXX001 with Serial Number 201081, System 23REV001XXX001 with Serial Number 201080, System 23REV001XXX001 with Serial Number 201079, System 23REV001XXX001 with Serial Number 201078, System 23REV001XXX001 with Serial Number 201077, System 23REV001XXX001 with Serial Number 201076, System 23CUP001CVX720 with Serial Number 201056 System 23CUP001CVMV4 with Serial Number 200921, System 23CUP001CVX720 with Serial Number 200920, System 23CAP001FXX001 with Serial Number 201004, System 23CUP001CVX720 with Serial Number 200922, System 23CUP003CVX720 with Serial Number 200749, System 23CUP001CVX720 with Serial Number 200748, System 23CUP001CVX720 with Serial Number 200747, System 23CUP001CVX720 with Serial Number 200996, System 23CUP003CVX720 with Serial Number 200980, System 23REV000KXX001 with Serial Number 200973, System 23REV000KXX001 with Serial Number 200972, System 23REV000KXX001 with Serial Number 200971, System 23CW4000UP002 with Serial Number 200962, System 23CW4000UP002 with Serial Number 200961 System 23CW4000UP002 with Serial Number 200960, System 23CW4000UP002 with Serial Number 200959, System 23CUP002CVX710 with Serial Number 200958, System 23CUP001CVX720 with Serial Number 201059, System 23REV000KFX001 with Serial Number 200702, System 23REV000KFX001 with Serial Number 200700, System 23REV000KXX001 with Serial Number 201014, System 23CUP001CVX720 with Serial Number 200770, System 23CAP007FXX001 with Serial Number 200892, System 23CAP001FXX001 with Serial Number 2009.28, System 23CUP003CVX720 with Serial Number 201019, System 23CUP003CVX720 with Serial Number 201017, System 23CUP003CVX720 with Serial Number 201016, System 23CAP002FXX001 with Serial Number 200693, System 23GSL120KXX001 with Serial Number 200907, System 23CAP003KFX001 with Serial Number 200936, System 23CAP001FXX001 with Serial Number 200888, System 23CAP001KXX001 with Serial Number 200731, System 23CAP001KXX001 with Serial Number 200730, System 23CUP003CVX720 with Serial Number 200729, System 23CUP003CVX720 with Serial Number 200728, System 23HDUWIN7CV72003 with Serial Number 108502, System 23MBX008KFX001 with Serial Number 200716, System 23CUP003CVX720 with Serial Number 200876, System 23CUP003CVX720 with Serial Number 200773, System 23CAP001FXX001 with Serial Number 200925, System 23CAP001FXX001 with Serial Number 200919System 23CW4000UP001 with Serial Number 200883, System 23CAP001KFX001 with Serial Number 200916, System 23CW4000UP001 with Serial Number 200991, System 23CW4000UP001 with Serial Number 200990, System 23CW4000UP001 with Serial Number 200984, System 23CAP003KFX001 with Serial Number 201075, System 23CAP001KXX001 with Serial Number 200718, System 23MBX008KFX001 with Serial Number 200733, System 23CUP001CVX720 with Serial Number 201022, System 23REV000KFX001 with Serial Number 200882, System 23CUP003CVX720 with Serial Number 200724, System 23GSLXXXKFXUPG with Serial Number 200723, System 23CAP003KFX001 with Serial Number 200977, System 23CAP001KFX001 with Serial Number 200934, System 23CAP001KFX001 with Serial Number 200933, System 23CUP003CVX720 with Serial Number 200737, System 23CUP003CVX720 with Serial Number 200736, System 23CUP003CVX720 with Serial Number 200735, System 23CUP003CVX720 with Serial Number 201012, System 23CUP003CVX720 with Serial Number 201011, System 23CUP003CVX720 with Serial Number 201010, System 23CUP003CVX720 with Serial Number 201009, System 23CUP003CVX720 with Serial Number 201008, System 23CUP003CVX720 with Serial Number 201007, System 23CUP003CVX720 with Serial Number 201006, System 23GSLXXXKFXUPG with Serial Number 201005, System 23CAP001FXX001 with Serial Number 200992, System 23CAP001FXX001 with Serial Number 2008.79, System 23CUP003CVX720 with Serial Number 200970, System 23CUP008CVXA10 with Serial Number 200968, System 23CUP008CVXA10 with Serial Number 200967, System 23CUP003CVX720 with Serial Number 200965, System 23CUP003CVX720 with Serial Number 200964, System 23CUP003CVX720 with Serial Number 200963, System 23CUP003CVX720 with Serial Number 200721, System 23CUP001CVX720 with Serial Number 200720, System 23GSLXXXKFXUPG with Serial Number 200719, System 23CUP006CVXA10 with Serial Number 200727, System 23CUP003CVX720 with Serial Number 200726, System 23CUP003CVX720 with Serial Number 200725, System 23CUP003CVX720 with Serial Number 200904, System 23CUP005CVMV4 with Serial Number 200903, System 23CUP005CVMV4 with Serial Number 200902, System 23CUP001CVX720 with Serial Number 200956, System 23CUP001CVX720 with Serial Number 200955, System 23CUP003CVX720 with Serial Number 201070, System 23CUP003CVX720 with Serial Number 200989, System 23CUP003CVX720 with Serial Number 200988, System 23CAP002FXX001 with Serial Number 200953, System 23GSL120KXX001 with Serial Number 201074, System 23GSL120KXX001 with Serial Number 201072, System 23GSL120KXX001 with Serial Number 201066, System 23GSL120KXX001 with Serial Number 201065, System 23GSL120KXX001 with Serial Number 201064, System 23GSL120KXX001 with Serial Number 201063, System 23GSL120KXX001 with Serial Number 201062, System 23GSL120KFX001 with Serial Number 201061, System 23GSL120KFX001 with Serial Number 201060, System 23GSLXXXKFXUPG with Serial Number 201058, System 23GSL120KXX001 with Serial Number 201057, System 23GSL120KXX001 with Serial Number 200927, System 23GSL120KXX001 with Serial Number 200926, System 23GSL120KXX001 with Serial Number 200923, System 23REV000KXX001 with Serial Number 200974, System 23GSL10XKXX001 with Serial Number 200957, System 23CAP001KXX001 with Serial Number 200941, System 23CAP001KXX001 with Serial Number 200940, System 23CAP001KXX001 with Serial Number 200895, System 23GSL120KXX001 with Serial Number 200423, System 23CAP001KFX001 with Serial Number 200924, System 23CAP002KFX001 with Serial Number 200983, System 23MBX008KFX001 with Serial Number 200995, System 23GSL120KFX001 with Serial Number 201053, System 23CAP001KFX001 with Serial Number 200734, System 23CUP001CVX720 with Serial Number 200722, System 23GSL120KXX001 with Serial Number 200954, System 23CUP003CVX720 with Serial Number 201047, System 23GSL120KFX001 with Serial Number 200772, System 23CW4000UP001 with Serial Number 200771, System 23CUP001CVX720 with Serial Number 200914, System 23CUP001CVX720 with Serial Number 200913, System 23GSLXXXKFXUPG with Serial Number 200912, System 23CUP001CVX720 with Serial Number 200911System 23CUP001CVX720 with Serial Number 200909, System 23CUP001CVX720 with Serial Number 200908, System 23CAP002KFX001 with Serial Number 201046, System 23REV000KXX001 with Serial Number 200901, System 23REV000KXX001 with Serial Number 200900, System 23REV000KXX001 with Serial Number 200899, System 23REV000KXX001 with Serial Number 200898, System 23GSL120KXX001 with Serial Number 200897, System 23REV000KFX001 with Serial Number 200878, System 23CAP003KFX001 with Serial Number 200877, System 23CAP001KXX001 with Serial Number 201068, System GSL 120 MKII with Serial Number 108457, System 23REV000KXX001 with Serial Number 201069 , System 23REV000KXX001 with Serial Number 201049, System 23REV001XXX001 with Serial Number 201048, System 23CUP003CVX720 with Serial Number 201043, System 23GSLXXXKFXUPG with Serial Number 201045, System 3CAP001KFX001 with Serial Number 201055, System 23CAP001KFX001 with Serial Number 201054, System 23MBX008KXX001 with Serial Number 200917, System 23GSL120KFX001 with Serial Number 200766, System 23GSL120KXX001 with Serial Number 200935, System 23GSL120KXXUG1 with Serial Number 201003, System 23GSL120KXX001 with Serial Number 200985, System 23GSL120KXX001 with Serial Number 200979, System 23CUP006CVXA10 with Serial Number 201042, System 23CUP006CVXA10 with Serial Number 201041,System 23REV001XXX001 with Serial Number 201040, System 23CUP006CVXA10 with Serial Number 201039, System 23CUP003CVX720 with Serial Number 200906, System 23CUP003CVX720 with Serial Number 200905, System 23GSLXXXKFXUPG with Serial Number 200711, System 23CUP003CVX720 with Serial Number 200707, System 23CAP001KFX001 with Serial Number 201002, System 23CUP003CVX720 with Serial Number 201044, System 23CUP003CVX720 with Serial Number 200894, System 23GSL10XKFX001 with Serial Number 200758, System 23REV000KFX001 with Serial Number 201038, System 23REV000KFX001 with Serial Number 201037, System 23REV000KFX001 with Serial Number 201036, System 23REV000KFX001 with Serial Number 201035, System 23GSL120KFX001 with Serial Number 201034, System 23REV000KFX001 with Serial Number 201033, System 23REV000KFX001 with Serial Number 201032, System 23REV000KFX001 with Serial Number 201031, System 23REV000KFX001 with Serial Number 201030, System 23GSL120KFX001 with Serial Number 201027, System 23CUP001CVX720 with Serial Number 200918, System 23CUP003CVX720 with Serial Number 201025, System 23CUP001CVX720 with Serial Number 201024, System 23CUP001CVX720 with Serial Number 201023, System 23GSL120KXX001 with Serial Number 200978, System 23CUP001CVX720 with Serial Number 200976, System 23CUP001CVX720 with Serial Number 200975, System 23CUP001CVX720 with Serial Number 200938, System 23GSL120KXX001 with Serial Number 201015, System 23CUP001CVMV4 with Serial Number 200932, System 23CUP001CVMV4 with Serial Number 200931, System 23CUP006CVXA10 with Serial Number 200709, System 23CUP006CVXA10 with Serial Number 200703, System 23CUP003CVX720 with Serial Number 200999, System 23CUP003CVX720 with Serial Number 200998, System 23GSLXXXKFXUPG with Serial Number 200997, System 23CUP006CVXA10 with Serial Number 200714, System 23CUP006CVXA10 with Serial Number 200713, System 23CUP003CVX720 with Serial Number 200712, System 23CUP003CVX720 with Serial Number 200769, System 23CUP003CVX720 with Serial Number 200768, System 23CUP003CVX720 with Serial Number 200767, System 23CUP003CVX720 with Serial Number 200765, System 23CUP003CVX720 with Serial Number 200764, System 23CUP003CVX720 with Serial Number 200763, System 23CUP003CVX720 with Serial Number 200762, System 23CUP006CVXA10 with Serial Number 200760, System 23CUP006CVXA10 with Serial Number 200759, System 23GSLXXXKFXUPG with Serial Number 200751, System 23GSLXXXKFXUPG with Serial Number 200750, System 23REV000KXX001 with Serial Number 200952, System 23REV000KXX001 with Serial Number 200951, System 23REV000KXX001 with Serial Number 200950, System 23REV000KXX001 with Serial Number 200949, System 23REV000KXX001 with Serial Number 200948, System 23REV000KXX001 with Serial Number 200947, System 23REV000KXX001 with Serial Number 200946, System 23REV000KXX001 with Serial Number 200945, System 23REV000KXX001 with Serial Number 200944, System 23REV000KXX001 with Serial Number 200943, System 23GSL120KXX001 with Serial Number 200939, System 23GSL120KXX001 with Serial Number 200937, System 23CAP001FXX001 with Serial Number 201029, System 23CAP001FXX001 with Serial Number 201028, System 23CAP003KFX001 with Serial Number 201026, System 23CAP001FXX001 with Serial Number 200757, System 23CAP001FXX001 with Serial Number 200756, System 23CAP001KFX001 with Serial Number 200754, System 23CAP001KFX001 with Serial Number 200753, System 23GSL120KFX001 with Serial Number 200717, System 23CUP005CVMV4 with Serial Number 200715, System 23CAP001FXX001 with Serial Number 200880, System 23CUP003CVX720 with Serial Number 200746, System 23CUP003CVX720 with Serial Number 200745, System 23CUP003CVX720 with Serial Number 200744, System 23CUP003CVX720 with Serial Number 200743, System 23CUP003CVX720 with Serial Number 200742, System 23CUP003CVX720 with Serial Number 200741, System 23CUP003CVX720 with Serial Number 200740, System 23CUP003CVX720 with Serial Number 200739, System 23CUP003CVX720 with Serial Number 200738, System 23GSL120KFX001 with Serial Number 200701, System 23CAP001KFX001 with Serial Number 200993, System 23GSL10XKFX001 with Serial Number 200708, System 23CAP001KFX001 with Serial Number 200706, System 23GSLXXXKFXUPG with Serial Number 200966, System 23CAP001KFX001 with Serial Number 201067, System 23CAP002KFX001 with Serial Number 200893, System 23CAP002KFX001 with Serial Number 200881, System 23CAP001KFX001 with Serial Number 200705, System 23CUP001CVX720 with Serial Number 200704, System 23CUP003CVX720 with Serial Number 200981, System 23REV000KFX001 with Serial Number 200887, System 23REV000KFX001 with Serial Number 200886, System 23CUP003CVX720 with Serial Number 200885, System 23CAP001KFX001 with Serial Number 200884, System 23REV000KXX001 with Serial Number 201052, System 23GSL10XKXX001 with Serial Number 201051, System 23GSL120KFX001 with Serial Number 200755, System 23GSL120KXX022 with Serial Number 200915, System 23CUP001CVX720 with Serial Number 200732, System 23GSL120KFX001 with Serial Number 200891, System 23GSL120KXX001 with Serial Number 201018, System CUS0014 with Serial Number 108498, System 23CUP003CVX720 with Serial Number 200889.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.
  • Product Description
    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Manufacturer Parent Company (2017)
  • Source
    USFDA