FDAFDA · Food and drugs·Recall number 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.

Published December 4, 2019 · Recall initiated: October 7, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

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

Recall details

Manufacturer: Beckman Coulter, Inc.
Distributor: 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.
Lot: 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,
Risk classification: Class II
Area (FDA): device
Country: United States

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