Events

Rappel de Device Recall EVOLIS Microplate System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Bio-Rad Laboratories, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73030
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0807-2016
  • Date de mise en oeuvre de l'événement
    2015-12-22
  • Date de publication de l'événement
    2016-02-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142855
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., 6565 185th Ave NE, Redmond WA 98052-5039
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA