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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66382
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only. Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277 AV05082 AV05092 AV11205 AT06076 AT09112 AT09114 AT16214 AT18235 AV11214 AV11217 AN30069 AS07008 AT09116 AS40361 AU05048 AU05054 AT48658 AS49426 AS49429 AV01023 AV01025 AM48043 AV06003 AT40542 AS15064 AT30380 AV01015 AS12050 AV06004 AV06151 AS12051 AS12052 AT01004 AU25303 AT36497 AT36499 AT36509 AV06127 AV06130 AV11231 AV14273 AV14275 AV27546 AV06141 AV01009 AV05104 AV09187 AV09192 AV09179 AU42632 AV06152 AV11238 AV14278 AV14283 AV28554 AV28559 AV23449 AV18362 AV09180 AV18364 AV24456 AV22393 AV11234 AV02072 AV05098 AV09184 AV02046 AV09191 AV09196 AV09197 AV24452 AT18242 AV09182 AV02051 AV02068 AV02076 AV06139 AV11236 AV12241 AV14287 AV28031 AV06147 AV11216 AV24490 AV26492 AV26498 AV26499 AS46412 AV12265 AV14266 AV05093 AV01032 AV14288 AV18373 AV26506 AV27512 AV02042 AU06070 AV06150 AV23424 AV26491 AV26495 AV26496 AV26500 AV26501 AV26503 AV26504 AV26505 AV27514 AV02064 AV18371 AV18375 AV01029 AV01031 AS43391 AS43392 AV01006 AV11232 AV23419 AV23423 AV28026 AV16315 AV16326 AN10031 AV01002 AV14294 AV18359 AV18365 AV27541 AV12260 AV05117 AV05120 AV27533 AV06154 AV06157 AV22386 AV28028 AV28595 AT44622 AV11202 AV27542 AV28564 AV22388 AT24332 AT27337 AV24467 AT42590 AV02044 AV02052 AV05095 AV05107 AV05109 AT27347 AN10025 AN20049 AS40359 AV12245 AV12247 AS24192 AV16337 AV16339 AU47779 AV14271 AN30064 AN30070 AV24457 AV24458 AV27537 AT02042 AU40574 AV14295 AT48660 AV23422 AT27343 AV28561 AN07022 AN10027 AT27345 AV02061 AT23288 AN42123 AT21265 AV27544 AV02070 AT18248 AV16336 AV06148 AV11221 AV11227 AV01008 AU05052 AV18358 AV18369 AV24465 AV24466 AV05096 AV01035 AV01038 AT23274 AV05099 AV18349 AV18366 AV28033 AV23439 AV24455 AV28029 AV28030 AU02003 AV05085 AV06140 AV22407 AV23430 AV27524 AV27528 AV28580 AV09172 AS27199 AS27204 AS27221 AS27222 AS30231 AS30232 AS30238 AS30242 AS30243 AS32248 AS32263 AS32264 AS32271 AS35282 AS40358 AT05074 AT09137 AT10144 AT50689 AV06145 AV11235 AV14284 AV14292 AV16327 AV16328 AV16343 AV18348 AV22390 AV23429 AV23432 AV24489 AV26494 AV27531 AV28571 AV28576 AS32249 AV02058 AT50690 AS49424 AV05108 AS35284 AV06134 AV06137 AV28557 AV28590 AS30228 AV22392 AV22387 AM51052 AV02057 AV02060 AV01036 AV24470 AV05087 AV02043 AV02049 AV06156 AV24473 AV24479 AV27515 AV27516 AV27529 AV27538 AV27540 AV16329 AV16332 AT06096 AM43032 AV11213 AV11215 AS02002 AV28566 AS23159 AU02019 AT23290 AT23297 AV27548 AS37334 AV28575 AV28582 AV01026 AV01027 AV26502 AV26510 AU49825 AV01005 AT16201 AV05118 AN33077 AT44598 AV28585 AV28592 AV14281 AV14282 AV27520 AV27522 AS24195 AS24196 AV05100 AV11203 AV11210 AV24451 AV27527 AV16321 AT30402 AT30404 AV02073 AT18228 AT18231 AV01010 AV05091 AU49823 AU49826 AV01013 AV18347 AV18353 AT40575 AV12255 AV12256 AV27523 AV27535 AT12164 AT12174 AV28579 AV28604 AV14291 AV09171 AN40110 AV01022 AV01024 AV28572 AV28577 AT36500 AV14298 AV14300 AV27534 AV27536 AV01039 AV05103 AV24476 AT40548 AT40549 AV02059 AV02074 AV11225 AV12246 AV24453 AU49824 AV01003 AT30397 AT30401 AV09195 AT24314 AT24316 AT30387 AT30394 AV02071 AV02075 AV09194 AV09198 AT06091 AT06094 AV12258 AV01007 AT23309 AV05094 AV05101 AV12253 AV12254 AV11220 AV09181 AV02047 AV02048 AN10033 AS27223 AS27225 AT27368 AT27370 AV16333 AV16335 AV24459 AV24460 AT16208 AV16313 AV16316 AT27359 AT40545 AT40555 AT40567 AT40571 AV05110 AV05115 AV06121 AT01008 AV09170 AV09178 AS12054 AT02038 AV14296 AV14299 AT18253 AT21261 AV09164 AV28563 AT27350 AT21264 AT40540 AT40544 AV09167 AT09103 AT46644 AV11212 AV11223 AS19106 AV12244 AV12257 AV12249 AV12251 AT18243 AS17096 AS37338 AS37341 AV11230 AV16341 AS15068 AU10088 AU10090 AV02045 AV16331 AV16334 AU14162 AV27539 AV12248 AV12252 AT46645 AT46647 AT46648 AV27545 AT48654 AT48655 AS27210 AS27215 AS46404 AS46406 AV16314 AV16318 AV01033 AV01037 AV11228 AV11233 AV09175 AV12264 AV06125 AV06136 AV12259 AT30385 AT30389 AU32446 AU32449 AV16312 AT18240 AT18244 AV14290 AV14305 AV16317 AV28558 AV28567 AV01040 AV24471 AV24472 AV24474 AS40363 AT23282 AT27367 AV11204 AV11209 AV11211 AN45136 AV09183 AV09199 AV11201 AV11206 AV14267 AV14268 AV01012 AV24488 AV26497 AV27518 AV27525 AV02050 AV16330 AV16340 AV23437 AT31410 AT31415 AN33082 AV01028 AV09174 AV23448 AV28598 AT31407 AT31414 AV28583 AV28599 AS49430 AV24468 AV02062 AV02063 AT40560 AV23411 AV11237 AV12262 AV27521 AT44626 AV11222 AV11224 AV28584 AV28601 AN30062 AU40556 AV18368 AV18377 AV27517 AV27526 AV14301 AV11207 AV11208 AS40365 AS40371 AV16342 AV02065 AV02069 AT21267 AT50692 AT27366 AS49425 AV14286 AV14289 AV05111 AV05116 AT09135 AT18249 AV05119 AV06123 AT36515 AV27530 AS19112 AV06159 AV09168 AS35300 AS35301 AN49156 AV24464 AV18350 AV18351 AV14297 AT27357 AV23418 AV27550 AV16320 AT16213 AT18219 AT05071 AT09106 AV18356 AV18360 AV18370 AT23304 AV18346 AV02066 AV05088 AT44619 AT24317 AV24462 AV24463 AV28573 AV28586 AV28587 AV02054 AV02055 AV02056 AV18363 AV18367 AV18372 AT50684 AV01019 AV24469 AV27532 AV28588 AV09188 AV27547 AV28552 AV23444 AT09127 AT09129 AT36503 AT36508 AV23426 AV23427 AV05105 AS37337 AS37339 AV14276 AV09189 AV09193 AV16338 AV22395 AU32447 AV16319 AT44601 AV06133 AV23447 AV28551 AV02053 AV16311 AV27511 AN38098 AN38104 AM51050 AU31414 AU31429 AT46643 AU19244 AU19251 AU14174 AT18225 AT24319 AT27342 AV02079 AN42121 AS21128 AU10103 AS27203 AS35285 AM32020 AN07021 AT27374 AT42585 AV28578 AV28591 AV23440 AV23450 AV14280 AV18376 AV14277 AV14279 AV23435 AV23442 AV23446 AV28593 AV28597 AV18378 AV18379 AV11218 AV11219 AU27366 AS21134 AV05081 AV02077 AN33078 AT40547 AN45150 AN49157 AN40119 AT31408 AS35290 AT24325 AN07019 AS36318 AV23416 AV23431 AS15075 AV06160 AS36315 AS17097 AS36306 AS37346 AS40348 AS46415 AS46417 AS15063 AV11239 AS27206 AS10039 AS35291 AN05010 AT02026 AS19102 AT16194 AS19103 AS02003 AS02004 AS10033 AV01030 AU02005 AV24313 AU23271 AV18381 AV22394 AV22396 AV22401 AV22406 AV22410 AV23412 AT36504 AU02007 AT05058 AT05063 AT16192 AT16202 AT24323 AT24326 AU12136 AU12142 AV28581 AV16309 AV16310 AV23438 AV23441 AV24454 AS17086 AS17082 AV24481 AV24483 AV16323 AV16325 AV16344 AV16345 AV18352 AV18354 AV18355 AS23168 AS23171 AU11133 AV23433 AU05036 AS37343 AS40352 AU36505 AS40356 AT23278 AU38531 AV09169 AV09173 AT27363 AS02005 AT44594 AT44605 AT44613 AS07018 AT02031 AV28574 AS30237 AU19238 AV06124 AV06135 AN40118 AN40120 AV27513 AS23154 AS30229 AT02022 AT23271 AV01001 AU12151 AT18250 AT42584 AT02027 AN45138 AU10102 AU49827 AV01004 AV11226 AV18383 AT02040 AN42124 AN49154 AV18382 AN33075 AV05089 AU14178 AT09104 AT12163 AS19119 AS21125 AU29380 AU29382 AN20057 AS32277 AT31427 AU25326 AU27333 AU27335 AN20060 AU45699 AT38519 AT38520 AS43384 AN20058 AN30066 AN40108 AT12175 AS19115 AS46402 AU32469 AU35472 AS37347 AS40364 AS40373 AT06089 AT01014 AT02036 AT02039 AT21262 AT24312 AT30406 AT31419 AT31424 AT31428 AS19113 AS21122 AS21124 AU44694 AU44695 AU44696 AS07015 AU10094 AU11110 AS40374 AT36487 AT38518 AT09102 AT10160 AT18233 AM32022 AS32269 AT30400 AV12261 AV12263 AN33079 AN38105 AV28555 AV28556 AV28562 AV23443 AT05059 AV12242 AV12243 AV16306 AV16307 AS21130 AS36324 AS37333 AS24174 AT06084 AT31441 AV01021 AT27371 AS17094 AV09162 AV09163 AV11240 AV22400 AS07029 AT24320 AT21257 AT30393 AT06079 AS17101 AS21136 AS24189 AT46650 AV16308 AT44597 AT01006 AS27211 AS27213 AV23420 AV23421 AS27202 AS30240 AS17088 AN42128 AT38527 AS17092 AT06080 AS07009 AV18357 AV18361 AV22397 AV22403 AV22404 AU02011 AV18384 AT06078 AS17093 AT18255 AU02013 AS27205 AT01018 AT02030 AV24475 AV24478 AV24480 AV05083 AV09165 AT42588 AT38532 AV01017 AV01018 AV01016 AV01020 AV06158 AV22405 AV05084 AV05090 AU40554 AV05086 AV05112 AV06146 AV05102 AU43642 AU43643 AV06142 AS21140 AV01014 AV06122 AV06128 AV14303 AV09161 AU27357 AU27363 AS49422 AU32439 AV14293 AV05106 AV06138 AT31416 AT31423 AV05113 AN40109 AN40111 AS17090 AT27341 AM51048 AS43393 AV16322 AV16324 AV05114 AV06129 AV06131 AV18374 AU49822 AV23415 AV23417 AU19245 AV09185 AV09186 AV23445 AT24330 AT36492 AT24329 AT36502 AU11129 AS23158 AU19243 AS24173 AT23286 AV12250 AV24482 AV23434 AV23428 AV01034 AV06155 AS36304 AV18385 AV22389 AV22391 AS32274 AV01011 AS36321 AV06011 AU48002 AV06010 AV06008 AV06001 AU51004 AV06007 Class II Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamber or Probe Waste Chamber. 1,025 units Z-0147-2014
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