EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in...
FDA Recall #Z-0807-2016 — Class II — December 22, 2015
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.
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.
Recalling Firm
Bio-Rad Laboratories, Inc. — Redmond, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
278 units
Distribution
US Nationwide Distribution including Puerto Rico.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated