—#177542

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K140911
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 SW 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-10-07
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177542. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.