Beckman Coulter, Inc.: 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.

Recall number

Z-0516-2020

Recalling firm

Beckman Coulter, Inc.

Product

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.

Status

Terminated

Initiated

2019-10-07

Posted

not on file

Terminated

2021-04-27

Reason

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.

Root cause

Under Investigation by firm

Action

Consignees were notified via email and mail with an Urgent Medical Device Recall letter, dated 10/02/2019. Four consignees were notified with a letter dated 10/18/2019. The letter identified affected product, stated the issue, provided action to be taken to determine if consignee is affected, and stated that a hardware change was in progress to eliminate the issue. A response form was asked to be returned. Questions can be directed to Beckman Coulter Customer Support Center at 800-526-7694.

Quantity

1,056 (418 US, and 638 OUS)

Distribution

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, serial or model codes

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.AY04017, AY04018, AY04019, AY04020, AY08021, AY08022, AY08023, AY08024, AY08025, AY08026, AY08027, AY08028, AY08029, AY08032, AY08033, AY08034, AY10036, AY10037, AY10038, AY10039, AY10040, AY10041, AY10042, AY10044, AY10045, AY10046, AY10047, AY10048, AY10049, AY10051, AY10053, AY10054, AY10055, AY17056, AY17057, AY17058, AY17059, AY17060, AY17061, AY17062, AY17063, AY17064, AY17065, AY19066, AY19067, AY19069, AY19070, AY19071, AY19072, AY19073, AY19074, AY19075, AY23076, AY23077, AY23078, AY23079, AY23080, AY23081, AY30085, AY30086, AY30087, AY30088, AY30090, AY32092, AY32093, AY32094, AY32095, AY32096, AY32097, AY32098, AY32099, AY32100, AY32101, AY32102, AY32103, AY32104, AY32105, AY32106, AY35107, AY35108, AY35109, AY35110, AY35111, AY35112, AY35113, AY35114, AY35115, AY35116, AY35117, AY35118, AY35119, AY35120, AY35121, AY40123, AY40124, AY40125, AY40126, AY41127, AY41128, AY41129, AY41130, AY41132, AY41133, AY41134, AY41140, AY41141, AY51142, AY51143, AY51144, AY51145, AY51149, AY52150, AY52151, AY52152, AY52153, AY52154, AY52155, AY52156, AY52157, AY52158, AY52159, AZ02001, AZ02002, AZ02004, AZ02006, AZ02007, AZ02008, AZ02009, AZ02010, AZ06011, AZ06012, AZ06013, AZ06014, AZ06015, AZ06016, AZ06017, AZ06018, AZ06020, AZ06021, AZ06022, AZ08023, AZ08024, AZ08025, AZ08026, AZ08027, AZ08028, AZ08029, AZ08030, AZ08031, AZ12033, AZ12034, AZ12035, AZ12038, AZ12040, AZ12042, AZ12043, AZ12044, AZ17045, AZ17046, AZ17048, AZ17050, AZ17051, AZ17053, AZ18054, AZ18055, AZ18056, AZ18057, AZ19058, AZ19059, AZ19060, AZ19061, AZ20062, AZ20063, AZ20064, AZ20065, AZ20066, AZ20067, AZ20068, AZ20069, AZ20070, AZ22071, AZ22072, AZ22073, AZ22074, AZ22075, AZ23077, AZ23078, AZ23079, AZ23080, AZ24081, AZ24082, AZ24083, AZ24084, AZ24085, AZ25087, AZ25088, AZ25089, AZ25090, AZ28091, AZ28092, AZ28093, AZ28094, AZ28095, AZ28096, AZ28097, AZ28098, AZ28099, AZ28100, AZ34101, AZ34102, AZ34103, AZ34104, AZ34105, AZ34106, AZ34107, AZ34108, AZ34109, AZ34110, AZ34111, AZ34112, AZ34113, AZ34114, AZ34115, AZ39116, AZ39118, AZ39119, AZ39120, AZ39121, AZ39122, AZ39123, AZ39124, AZ39125, AZ41127, AZ41131, AZ41132, AZ41133, AZ41134, AZ41135, AZ43136, AZ43137, AZ43138, AZ43139, AZ43140, AZ43141, AZ43143, AZ46146, AZ46147, AZ46148, AZ46149, AZ46150, AZ46151, AZ46152, AZ46156, AZ46157, AZ46158, AZ46159, AZ48160, AZ48162, AZ48163, AZ48164, AZ48166, AZ48167, AZ49168, AZ49169, AZ49170, AZ49172, AZ49173, AZ49174, AZ49175, AZ49176, BA03001, BA03002, BA03003, BA03004, BA03005, BA03006, BA03007, BA03008, BA03009, BA03010, BA07011, BA07012, BA07013, BA07014, BA07015, BA07016, BA07017, BA07018, BA07019, BA07020, BA08021, BA08022, BA08023, BA08024, BA08025, BA10026, BA10027, BA10028, BA10029, BA10030, BA10031, BA13032, BA13034, BA13035, BA13036, BA13037, BA13038, BA13039, BA13040, BA13041, BA15042, BA15045, BA16047, BA16048, BA16049, BA16050, BA17052, BA17053, BA17054, BA18055, BA18056, BA18057, BA19060, BA19061, BA19062, BA21064, BA22067, BA22068, BA22069, BA22070, BA23071, BA23072, BA23073, BA24075, BA24076, BA24077, BA24078, BA25080, BA25081, BA25082, BA25083, BA25084, BA25085, BA27086, BA27087, BA27088, BA27089, BA27090, BA29091, BA29092, BA29093, BA29094, BA29095, BA31096, BA31097, BA31098, BA31099, BA31100, BA35101, BA35103, BA35104, BA35105, BA36106, BA36107, BA37109, BA37110, BA37111, BA37112, BA38113, BA38114, BA38115, BA40116, BA40117, BA40118, BA41119, BA41120, BA41121, BA41122, BA43124, BA43126, BA46127, BA46128, BA46129, BA46130, BA48131, BA48132, BA48133, BA49134, BA49135, BA49136, BA49137, BA50138, BA50139, BA50140, BA50141, BA50142, BB03001, BB03002, BB03003, BB03004, BB04005, BB04006, BB05007, BB05008, BB05009, BB06010, BB09011, BB09012, BB09013, BB09014, BB09015, BB16016, BB16017, BB16018, BB16019, BB16021, BB16022, BB16023, BB23024, BB23025, BB23026, BB23027, BB23028, BB27029, BB27030, BB27031, BB27032, BB27033, BB27034, BB47045, BB47046, BB47047, BB47048, BB47049, BB47050, BB47051, BB47052, BB47053, BB47054, BC01001, BC01002, BC01003, BC01004, BC04006, BC04007, BC04008, BC10016, BC10017, BC10018, BC10019, BC14021, BC14022, BC14023, BC14024, BC21026, BC21027, BC29030, BC29031, BC29032, BC29035, BC30036, BC30039.   Catalog Number B66705.  Serial Numbers: AZ30002, AZ30003, AZ30004, AZ39005, BA14002.   Catalog Number C11477. Serial Numbers: BB11109, BB11110, BB12111, BB12117, BB12118, BB12119, BB12120, BB12121, BB12122, BB12123, BB18124, BB18125, BB18126, BB18127, BB18128, BB18129, BB18130, BB18133, BB23134, BB23135, BB23136, BB31145, BB31146, BB31147, BB31148, BB31149, BB31150, BB36157, BB36158, BB36159, BB36160, BB36161, BB36162, BB43163, BB43164, BB43165, BB43166, BB43167, BB43168, BB47169, BB47170, BB47171, BB47172, BB47173, BB47174, BB47176, BB47177, BC01101, BC01102, BC01103, BC01104, BC01105, BC04106, BC04108, BC04109, BC04110, BC04111, BC04112, BC04113, BC04114, BC04115, BC09117, BC09118, BC09119, BC09120, BC09121, BC09122, BC09123, BC09124, BC09125, BC09126, BC09127, BC09128, BC14131, BC14132, BC14133, BC14134, BC14135, BC14136, BC14137, BC14138, BC14140, BC14141, BC14142, BC14143, BC14144, BC14145, BC19146, BC19147, BC19148, BC19149, BC19150, BC19151, BC19152, BC19153, BC19154, BC19155, BC19156, BC19157, BC21158, BC21159, BC21160, BC21161, BC21162, BC21163, BC21164, BC21166, BC21169, BC21171, BC24172, BC24173, BC24174, BC24175, BC24176, BC24178, BC24180, BC24181, BC30182, BC30183, BC30184, BC30185, BC30186, BC30187, BC30188, BC30189, BC30190, BC30191, BC33192, BC33193, BC33194, BC33195, BC33196, BC33197, BC33198, BC33200, BC33201, BC33202, BC33203, BC33204, BC33206, BC36207, BC36208, BC36209, BC36210, BC36211, BC36212, BC36213, BC36214, BC36215.

510(k) numbers

["K140911"]

PMA numbers

not on file

Product code

GKZ

Firm FEI

3000203293

Firm city

Miami

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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