Events

Recall of Device Recall EVOLIS Microplate System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories, 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
    73030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0807-2016
  • Event Initiated Date
    2015-12-22
  • Event Date Posted
    2016-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142855
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The error "washer reagent clean fluid" level low alarmed, which prompted the customer to open the system drawer. when the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
  • Action
    Bio-Rad sent an Urgent Product Notification letter, dated December 22, 2015, to consignees via Fed-Ex. The firm recognized the typographical error of the PN number on the first letter and sent a revised notification letter, dated 20 January 2016, with the correct PN 89788 to consignees. The letter identified the affected product, problem and actions to be taken. Consignees are advised that in addition to the WARNING in Chapter 4.9.2 in the EVOLIS Operators Manual (PN 89788) mention is made of, "LED lamps on the front panel of the EVOLIS instrument illuminate when a compartment may be accessed. If an error occurs, (for example a bulk reagent becomes depleted) the system displays an error message, pauses, and allows access to the instrument compartments." The plate transport may still be moving the microplate to its final destination when access is allowed. To enhance safety features, your Field Safety Engineer (FSE) will apply a (yellow) warning label to the lower front panel. Labels are currently on order and once received will be provided to each FSE. The label will state: WARNING! Before opening instrument, ensure all moving parts have stopped". Consignees can contact Bio-Rad Technical Support directly at 1-800-224-6723, option #2, and then option #3 or by fax at 425-498-1628.

Device

Device Recall EVOLIS Microplate System
  • Model / Serial
    The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number.  SERIAL NUMBERS:  9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530, 9163700531, 9163700544, 9163700556, 9163700558, 9163700559, 9163700560, 9163700567, 9163700585, 9163700587, 9163700594, 9163700595, 9163700623, 9163700624, 9163700625, 9163700629, 9163700656, 9163700695, 9163700696, 9163700722, 9163700743, 9163700744, 9163700745, 9163700764, 9163700765, 9163700772, 9163700775, 9163700776, 9163700810, 9163700821, 9163700822, 9163700823, 9163700835, 9163700836, 9163700843, 9163700844, 9163700846, 9163700850, 9163700851, 9163700853, 9163700855, 9163700857, 9163700862, 9163700863, 9163700864, 9163700868, 9163700873, 9163700874, 9163700875, 9163700877, 9163700879, 9163700883, 9163700884, 9163700885, 9163700887, 9163700888, 9163700889, 9163700890, 9163700891, 9163700892, 9163700893, 9163700895, 9163700898, 9163700899, 9163700901, 9163700902, 9163700906, 9163700907, 9163700909, 9163700910, 9163700911, 9163700912, 9163700913, 9163700914, 9163700916, 9163700917, 9163700918, 9163700919, 9163700920, 9163700921, 9163700922, 9163700926, 9163700927, 9163700928, 9163700929, 9163700930, 9163700931, 9163700932, 9163700933, 9163700934, 9163700935, 9163700936, 9163700937, 9163700938, 9163700939, 9163700941, 9163700942, 9163700943, 9163700945, 9163700946, 9163700947, 9163700948, 9163700949, 9163700950, 9163700952, 9163700956, 9163700957, 9163700959, 9163700960, 9163700961, 9163700962, 9163700964, 9163700965, 9163700966, 9163700967, 9163700968, 9163700972, 9163700973, 9163700974, 9163700975, 9163700977, 9163700978, 9163700979, 9163700980, 9163700981, 9163700982, 9163700984, 9163700985, 9163700987, 9163700988, 9163700989, 9163700991, 9163700992, 9163700993, 9163700996, 9163700997, 9163700998, 9163700999, 9163701000, 9163701001, 9163701002, 9163701003, 9163701004, 9163701005, 9163701006, 9163701007, 9163701008, 9163701009, 9163701010, 9163701011, 9163701012, 9163701013, 9163701014, 9163701015, 9163701017, 9163701018, 9163701019, 9163701020, 9163701021, 9163701022, 9163701023, 9163701024, 9163701025, 9163701026, 9163701027, 9163701028, 9163701029, 9163701030, 9163701031, 9163701032, 9163701033, 9163701034, 9163701035, 9163701036, 9163701037, 9163701038, 9163701039, 9163701040, 9163701041, 9163701042, 9163701043, 9163701044, 9163701045, 9163701046, 9163701047, 9163701048, 9163701049, 9163701051, 9163701052, 9163701053, 9163701054, 9163701056, 9163701057, 9163701058, 9163701059, 9163701060, 9163701061, 9163701063, 9163700168R, 9163700172R, 9163700176R, 9163700202R, 9163700206R, 9163700209R, 9163700215R, 9163700221R, 9163700234R, 9163700236R, 9163700242R, 9163700246R, 9163700247R, 9163700276R, 9163700281R, 9163700282R, 9163700293R, 9163700294R, 9163700296R, 9163700326R, 9163700327R, 9163700330R, 9163700355R, 9163700359R, 9163700397R, 9163700398R, 9163700400R, 9163700432R, 9163700479R, 9163700494R, 9163700562R, 9163700563R, 9163700564R, 9163700565R, 9163700573R, 9163700617R, 9163700811R, 9163700834R, 9163700837R, 9163700878R, 9163700881R, 9163700886R, 9163700904R, 9163700908R, 9163700915R, 9163700925R, 9163700951R, 9163700958R, 9163700969R, 9163700971R, 9163700986R, and 916370726R.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico.
  • Product Description
    EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic || Product Usage: || EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA