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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

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  Class 2 Device Recall UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System see related information
Date Initiated by Firm August 04, 2016
Create Date August 30, 2016
Recall Status1 Terminated 3 on October 06, 2016
Recall Number Z-2692-2016
Recall Event ID 74875
510(K)Number K140911  K151954  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222
UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear
Code Information AZ28094 AW01001 AY01010 AY04011 AW20069 AV14059 AZ12033 AZ12034 AZ06021 AY52153 AV01003 AT40021 AV22105 AV12048 AZ12039 AU01015 AU40218 AU40217 AV22099 AU36203 AU36202 AV01012 AW35121 AW35120 AY08031 AU40222 AU11071 AV01008 AY52154 AY52152 AY23080 AV16090 AT49047 AV42151 AV44158 AY10040 AW20067 AW16061 AU40221 AU11070 AW28093 AW10045 AV16079 AV14065 AU01032 AV10042 AU49257 AZ08032 AW23075 AY17061 AY17063 AW35124 AU21134 AW42129 AW20065 AY04013 AU14087 AV48179 AV49181 AW49163 AY01009 AZ22072 AW01010 AU19114 AT35018 AT35017 AT40020 AV06026 AV06030 AY19075 AU08046 AU29170 AU01027 AT49051 AV49183 AZ02004 AZ06022 AU43236 AU20131 AU01005 AU01004 AV01016 AU14086 AW01015 AW06026 AW06024 AV16085 AU01029 AZ02010 AU19116 AZ22073 AZ22074 AZ12041 AZ12042 AZ25090 AZ28091 AY30082 AY30083 AY10054 AY10037 AY04015 AY32106 AY10055 AV01005 AU23152 AU28154 AY35118 AU20123 AU36204 AU13078 AW45141 AY41137 AU28159 AY35110 AU08045 AU08042 AV27119 AV39133 AU16106 AV36129 AV36130 AY01006 AW49162 AV48178 AU30179 AU35188 AW16053 AU36193 AV48177 AU11051 AW20064 AW35113 AU35187 AU28162 AV40142 AV12052 AU11063 AV21094 AY32094 AU43226 AV10035 AV01004 AV01007 AY01002 AY01004 AZ20070 AU20124 AU01017 AU01021 AU14083 AU16104 AU01031 AZ24084 AV06024 AU30175 AU11066 AU19121 AU08044 AZ08030 AU23151 AY19074 AU19120 AV12054 AU19119 AV16081 AU16107 AV39134 AT45034 AU01002 AU01026 AV40140 AW35115 AV44161 AV44163 AZ24083 AZ24085 AW06028 AW09032 AW09033 AV21096 AV21093 AV21095 AT49063 AU43240 AW35116 AV14060 AZ06018 AZ17048 AW16056 AV23112 AU43237 AV49190 AU43225 AW09031 AU08041 AZ18054 AV12047 AU13073 AV10038 AY30090 AU43233 AW10039 AW09035 AU08050 AV49184 AU11064 AU14091 AW20066 AU13082 AZ25087 AZ25086 AU28155 AU28157 AU19113 AV01009 AW10042 AW23079 AW49158 AV14070 AW45145 AW16058 AW16059 AY19068 AW28097 AY08030 AU29163 AV36127 AW06030 AW06029 AZ06015 AZ06016 AZ06017 AV40136 AV40137 AU30182 AW06025 AU08047 AU08049 AU43234 AU13079 AY51149 AU23149 AU43223 AU43230 AU43239 AW45140 AU14085 AV12049 AW49164 AW49165 AT49064 AY23077 AV22104 AV10034 AV49187 AZ20064 AV44157 AY35114 AT45036 AY01005 AU29169 AU13075 AV40145 AW45144 AW23074 AT49039 AW28090 AU30181 AU36190 AU36191 AT49065 AT49037 AU13077 AW01002 AU01014 AY52151 AW06027 AV27120 AU49256 AT40024 AV16082 AU20126 AZ19061 AY10048 AZ19060 AV14063 AU29164 AZ02007 AU40214 AV06019 AW28088 AV01011 AZ17049 AV12051 AW01005 AY01007 AY10051 AW28087 AV47166 AW01009 AV14068 AT35016 AU21133 AY08035 AY41136 AV14064 AW28098 AU13074 AU01013 AU16109 AU13081 AU13080 AU13076 AY52159 AZ02001 AZ28093 AZ28092 AV10036 AV10039 AV10033 AV48180 AU19117 AU16103 AV51191 AY04019 AU40205 AU40216 AV22102 AV48174 AW01011 AW45143 AW45142 AY10042 AU29171 AV23108 AU11057 AV44160 AW35114 AV10041 AV44159 AW16060 AV40144 AW47150 AU35183 AU43228 AU14088 AU01010 AU01011 AV23114 AV06025 AY23079 AW31108 AW09034 AU11065 AU40208 AY19069 AY19070 AW31100 AT49052 AT49055 AU36189 AZ08031 AV01013 AT49059 AU43231 AU11058 AZ20066 AZ20067 AZ20068 AZ20069 AV14061 AV14057 AY10038 AU19115 AY52150 AU36198 AU14084 AW45135 AW45134 AU40213 AU20125 AU11061 AU23146 AW35126 AW35125 AY04018 AY04017 AU49259 AU01024 AU01023 AU01025 AW31101 AW35123 AW35122 AW47148 AY17064 AV39135 AY08027 AY17060 AU36192 AU01019 AU11059 AW14046 AU11062 AV42147 AU19118 AV01010 AV39132 AU16111 AT49049 
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
FDA Determined
Cause 2
Under Investigation by firm
Action Beckman Coulter sent an Urgent Medical Device recall letter dated August 4, 2016, to all affected customers to inform them that the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the recall notice were instructed to contact Beckman Coulter Customer Support Center: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in the United States and Canada; and outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 759 units total (358 units in US)
Distribution Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = BSZ and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.