FDAFDA · Alimentos y medicamentos·N.º oficial Z-0147-2014
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.
Publicado el 13 de noviembre de 2013 · Inicio del retiro: 24 de septiembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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 Chamb
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- 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. .
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States