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U.S. Department of Health and Human Services

Class 2 Device Recall EVOLIS Microplate System

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  Class 2 Device Recall EVOLIS Microplate System see related information
Date Initiated by Firm December 22, 2015
Date Posted February 13, 2016
Recall Status1 Open3, Classified
Recall Number Z-0807-2016
Recall Event ID 73030
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Bio-Rad Laboratories, Inc.
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact BioRad Technical Support
800-224-6723 Ext. 2
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Use error
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.
Quantity in Commerce 278 units
Distribution US Nationwide Distribution including Puerto Rico.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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