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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0516-2020

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: 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.

Publicado el 4 de diciembre de 2019 · Inicio del retiro: 7 de octubre de 2019

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

When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Beckman Coulter, Inc.
Distribuidor
Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Lote
Catalog Number 775222. Serial numbers: AS39017, AS40018, AT35013, AT35014, AT35015, AT35017, AT35018, AT40020, AT40021, AT40022, AT40024, AT40025, AT40027, AT40030, AT45031, AT45032, AT45034, AT45035, AT49037, AT49041, AT49044, AT49045, AT49046, AT49047, AT49048, AT49049, AT49050, AT49051, AT49055, AT49057, AT49058, AT49059, AT49060, AT49061, AT49062, AT49063, AT49064, AT49065, AU01004, AU01005, AU01007, AU01009, AU01010, AU01011, AU01012, AU01014, AU01015, AU01016, AU01017, AU01020, AU01021, AU01022, AU01023, AU01024, AU01025, AU01028, AU01029, AU01030, AU08041, AU08043, AU08044, AU08047, AU08048, AU08049, AU08050, AU11051, AU11053, AU11057, AU11058, AU11059, AU11061, AU11062, AU11063, AU11064, AU11066, AU11068, AU11072, AU13073, AU13075, AU13077, AU13079, AU14083, AU14084, AU14085, AU14086, AU14087, AU14088, AU14090, AU16104, AU16111, AU16112, AU19113, AU19115, AU19118, AU19119, AU19120, AU20123, AU20124, AU20125, AU20128, AU20129, AU20130, AU20131, AU21133, AU21136, AU21137, AU21141, AU23146, AU23147, AU23149, AU23150, AU23151, AU23152, AU28153, AU28154, AU28160, AU28161, AU29163, AU29165, AU29167, AU29168, AU29169, AU29172, AU30173, AU30178, AU30180, AU30181, AU30182, AU35183, AU35185, AU35186, AU35187, AU35188, AU36189, AU36192, AU36193, AU36196, AU36198, AU36200, AU36201, AU36202, AU36203, AU36204, AU40205, AU40207, AU40209, AU40210, AU40211, AU40213, AU40214, AU40215, AU40216, AU40217, AU40218, AU40221, AU43223, AU43225, AU43226, AU43228, AU43229, AU43231, AU43232, AU43233, AU43234, AU43235, AU43237, AU43240, AU49254, AU49256, AU49259, AV01003, AV01004, AV01005, AV01007, AV01009, AV01010, AV01011, AV01012, AV01013, AV01014, AV01016, AV06018, AV06020, AV06023, AV06026, AV06028, AV06030, AV10033, AV10034, AV10035, AV10036, AV10038, AV10039, AV10042, AV10044, AV10045, AV12047, AV12049, AV12054, AV12055, AV12056, AV14057, AV14059, AV14061, AV14062, AV14063, AV16072, AV16073, AV16075, AV16077, AV16078, AV16080, AV16082, AV16083, AV16086, AV16088, AV16089, AV16090, AV16091, AV21092, AV21093, AV21095, AV21096, AV22097, AV22100, AV22102, AV22105, AV22106, AV23107, AV23109, AV23110, AV23111, AV23112, AV23113, AV23116, AV27117, AV27118, AV27120, AV27121, AV36127, AV36128, AV36129, AV36130, AV39131, AV39132, AV39133, AV39134, AV39135, AV40136, AV40137, AV40139, AV40140, AV40143, AV40145, AV42147, AV42149, AV42150, AV42151, AV42152, AV42153, AV42154, AV42155, AV44156, AV44157, AV44158, AV44160, AV44161, AV44162, AV44163, AV44164, AV47167, AV47168, AV47169, AV47170, AV48171, AV48173, AV48174, AV48176, AV48177, AV48178, AV48179, AV49181, AV49183, AV49184, AV49185, AV49187, AV49188, AV49189, AV51191, AV51192, AW01001, AW01002, AW01007, AW01008, AW01010, AW01011, AW01012, AW01013, AW01014, AW01015, AW06016, AW06018, AW06019, AW06020, AW06021, AW06023, AW06024, AW06025, AW06026, AW06027, AW06028, AW06029, AW09031, AW09032, AW09033, AW09034, AW09035, AW10036, AW10037, AW10038, AW10039, AW10040, AW10041, AW10044, AW10045, AW14046, AW14048, AW14049, AW14051, AW16052, AW16053, AW16054, AW16056, AW16057, AW16058, AW16059, AW16060, AW16061, AW20062, AW20063, AW20064, AW20065, AW20066, AW20067, AW20068, AW20069, AW20070, AW20071, AW23072, AW23073, AW23074, AW23075, AW23076, AW23077, AW23078, AW23079, AW28087, AW28088, AW28089, AW28090, AW28091, AW28094, AW28095, AW28096, AW28097, AW28098, AW31099, AW31100, AW31102, AW31103, AW31104, AW31105, AW31106, AW31107, AW31108, AW31109, AW31110, AW35111, AW35112, AW35113, AW35114, AW35115, AW35116, AW35117, AW35120, AW35121, AW35122, AW35123, AW35124, AW35125, AW35126, AW35127, AW35128, AW42129, AW42131, AW42132, AW42133, AW45134, AW45135, AW45136, AW45137, AW45138, AW45139, AW45140, AW45141, AW45143, AW45144, AW45145, AW45146, AW45147, AW47148, AW47149, AW47151, AW47152, AW47153, AW47154, AW47155, AW47156, AW47157, AW49159, AW49160, AW49161, AW49162, AW49163, AW49164, AW49165, AY01001, AY01002, AY01004, AY01005, AY01006, AY01007, AY01008, AY01009, AY01010, AY04011, AY04012, AY04013, AY04015, AY04016,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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