Class 2 Device Recall UniCel DxH Slidemaker Stainer, UniCel DxH Slidemaker Stainer II

• Date Initiated by Firm: October 07, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on April 27, 2021
• Recall Number: Z-0516-2020
• Recall Event ID: 84186
• 510(K)Number: K140911
• Product Classification: Counter, differential cell - Product Code GKZ
• 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.
• Code Information: 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, 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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.
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 11800 SW 147th Ave; Miami FL 33196-2500
• For Additional Information Contact: Customer Support Center; 800-526-7694
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GKZ and Original Applicant = BECKMAN COULTER, INC.