Beckman Coulter Inc. Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
All serial numbers installed before 5/20/2019: Serials numbers in the U.S.: PW211409002, PW211501005, PW211501006, PW211501007, PW211501008, PW211501013, PW211505001, PW211508003, PW211509002, PW211510001, PW211510002, PW211511001, PW211511002, PW211511003, PW211511005, PW211512001, PW211601001, PW211601002, PW211602002, PW211602003, PW211602004, PW211603001, PW211603002, PW211603003, PW211604001, PW211604002, PW211604005, PW211604006, PW211604009, PW211604010, PW211605001, PW211605002, PW211605004, PW211605005, PW211605006, PW211605007, PW211606005, PW211606007, PW211607001, PW211607004, PW211607005, PW211607009, PW211607017, PW211607018, PW211608001, PW211608006, PW211610002, PW211610006, PW211610007, PW211610008, PW211610011, PW211611001, PW211611002, PW211611003, PW211611004, PW211611005, PW211612003, PW211612006, PW211612007, PW211612008, PW211612010, PW211612013, PW211701001, PW211701010, PW211701013, PW211703004, PW211706008, PW211706009, PW211707005, PW211707006, PW211707007, PW211707009, PW211707011, PW211707012, PW211708008, PW211708009, PW211708010, PW211709004, PW211709011, PW211710001, PW211710009, PW211710010, PW211710012, PW211711002, PW211711004, PW211711007, PW211712001, PW211802013, PW211804005, PW211804006, PW211807006, and PW211807008. Serial numbers OUS: PW201607008, PW211409001, PW211501001, PW211501002, PW211501003, PW211501004, PW211501010, PW211501011, PW211501012, PW211506001, PW211506002, PW211506003, PW211506004, PW211506005, PW211506006, PW211506007, PW211507001, PW211507002, PW211507003, PW211507004, PW211508001, PW211508002, PW211508004, PW211509001, PW211510003, PW211511004, PW211512002, PW211512003, PW211601005, PW21160113, PW21160114, PW211602001, PW211602005, PW211602006, PW211603004, PW211603005, PW211603006, PW211604003, PW211604004, PW211604007, PW211604008, PW211605008, PW211606001, PW211606002, PW211606003, PW211606004, PW211606006, PW211606008, PW211607002, PW211607003, PW211607006, PW211607007, PW211607010, PW211607011, PW211607012, PW211607013, PW211607014, PW211607015, PW211607016, PW211608002, PW211608003, PW211608004, PW211608005, PW211610003, PW211610004, PW211610005, PW211610009, PW211610010, PW211611006, PW211612001, PW211612002, PW211612005, PW211612009, PW211612012, PW211701002, PW211701003, PW211701004, PW211701005, PW211701006, PW211701007, PW211701008, PW211701011, PW211701012, PW211701014, PW211702001, PW211702002, PW211702003, PW211702004, PW211702005, PW211702006, PW211702007, PW211702008, PW211703001, PW211703002, PW211703003, PW211703005, PW211703006, PW211703007, PW211703008, PW211703009, PW211703010, PW211703011, PW211706001, PW211706002, PW211706003, PW211706004, PW211706005, PW211706006, PW211706007, PW211706010, PW211706011, PW211706012, PW211706013, PW211707001, PW211707002, PW211707003, PW211707004, PW211707010, PW211708001, PW211708002, PW211708003, PW211708004, PW211708005, PW211708006, PW211708007, PW211709001, PW211709002, PW211709003, PW211709005, PW211709006, PW211709007, PW211709009, PW211709010, PW211709012, PW211710002, PW211710003, PW211710004, PW211710005, PW211710006, PW211710007, PW211710008, PW211710011, PW211711003, PW211712002, PW211712003, PW211712004, PW211712005, PW211712006, PW211712007, PW211712008, PW211712009, PW211712010, PW211801001, PW211801002, PW211801005, PW211801006, PW211801007, PW211801008, PW211801009, PW211801010, PW211801011, PW211801012, PW211802001, PW211802002, PW211802003, PW211802004, PW211802005, PW211802008, PW211802009, PW211802012, PW211802014, PW211802015, PW211802016, PW211803001, PW211803002, PW211803003, PW211803004, PW211803005, PW211804001, PW211804002, PW211804003, PW211804004, PW211804010, PW211804011, PW211804012, PW211804013, PW211804014, PW211804015, PW211804016, PW211804017, PW211804018, PW211804019, PW211805001, PW211805004, PW211805005, PW211805006, PW211805007, PW211806007, and PW212612004.
Products Sold
All serial numbers installed before 5/20/2019: Serials numbers in the U.S.: PW211409002, PW211501005, PW211501006, PW211501007, PW211501008, PW211501013, PW211505001, PW211508003, PW211509002, PW211510001, PW211510002, PW211511001, PW211511002, PW211511003, PW211511005, PW211512001, PW211601001, PW211601002, PW211602002, PW211602003, PW211602004, PW211603001, PW211603002, PW211603003, PW211604001, PW211604002, PW211604005, PW211604006, PW211604009, PW211604010, PW211605001, PW211605002, PW211605004, PW211605005, PW211605006, PW211605007, PW211606005, PW211606007, PW211607001, PW211607004, PW211607005, PW211607009, PW211607017, PW211607018, PW211608001, PW211608006, PW211610002, PW211610006, PW211610007, PW211610008, PW211610011, PW211611001, PW211611002, PW211611003, PW211611004, PW211611005, PW211612003, PW211612006, PW211612007, PW211612008, PW211612010, PW211612013, PW211701001, PW211701010, PW211701013, PW211703004, PW211706008, PW211706009, PW211707005, PW211707006, PW211707007, PW211707009, PW211707011, PW211707012, PW211708008, PW211708009, PW211708010, PW211709004, PW211709011, PW211710001, PW211710009, PW211710010, PW211710012, PW211711002, PW211711004, PW211711007, PW211712001, PW211802013, PW211804005, PW211804006, PW211807006, and PW211807008. Serial numbers OUS: PW201607008, PW211409001, PW211501001, PW211501002, PW211501003, PW211501004, PW211501010, PW211501011, PW211501012, PW211506001, PW211506002, PW211506003, PW211506004, PW211506005, PW211506006, PW211506007, PW211507001, PW211507002, PW211507003, PW211507004, PW211508001, PW211508002, PW211508004, PW211509001, PW211510003, PW211511004, PW211512002, PW211512003, PW211601005, PW21160113, PW21160114, PW211602001, PW211602005, PW211602006, PW211603004, PW211603005, PW211603006, PW211604003, PW211604004, PW211604007, PW211604008, PW211605008, PW211606001, PW211606002, PW211606003, PW211606004, PW211606006, PW211606008, PW211607002, PW211607003, PW211607006, PW211607007, PW211607010, PW211607011, PW211607012, PW211607013, PW211607014, PW211607015, PW211607016, PW211608002, PW211608003, PW211608004, PW211608005, PW211610003, PW211610004, PW211610005, PW211610009, PW211610010, PW211611006, PW211612001, PW211612002, PW211612005, PW211612009, PW211612012, PW211701002, PW211701003, PW211701004, PW211701005, PW211701006, PW211701007, PW211701008, PW211701011, PW211701012, PW211701014, PW211702001, PW211702002, PW211702003, PW211702004, PW211702005, PW211702006, PW211702007, PW211702008, PW211703001, PW211703002, PW211703003, PW211703005, PW211703006, PW211703007, PW211703008, PW211703009, PW211703010, PW211703011, PW211706001, PW211706002, PW211706003, PW211706004, PW211706005, PW211706006, PW211706007, PW211706010, PW211706011, PW211706012, PW211706013, PW211707001, PW211707002, PW211707003, PW211707004, PW211707010, PW211708001, PW211708002, PW211708003, PW211708004, PW211708005, PW211708006, PW211708007, PW211709001, PW211709002, PW211709003, PW211709005, PW211709006, PW211709007, PW211709009, PW211709010, PW211709012, PW211710002, PW211710003, PW211710004, PW211710005, PW211710006, PW211710007, PW211710008, PW211710011, PW211711003, PW211712002, PW211712003, PW211712004, PW211712005, PW211712006, PW211712007, PW211712008, PW211712009, PW211712010, PW211801001, PW211801002, PW211801005, PW211801006, PW211801007, PW211801008, PW211801009, PW211801010, PW211801011, PW211801012, PW211802001, PW211802002, PW211802003, PW211802004, PW211802005, PW211802008, PW211802009, PW211802012, PW211802014, PW211802015, PW211802016, PW211803001, PW211803002, PW211803003, PW211803004, PW211803005, PW211804001, PW211804002, PW211804003, PW211804004, PW211804010, PW211804011, PW211804012, PW211804013, PW211804014, PW211804015, PW211804016, PW211804017, PW211804018, PW211804019, PW211805001, PW211805004, PW211805005, PW211805006, PW211805007, PW211806007, and PW212612004.
Beckman Coulter Inc. is recalling Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; an due to Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 5/8/2019 on 5/17/2019 informing the customers of the issue and that a spilled sample could lead to exposure of biohazardous material and that a software update would be made by their field service engineers at the next service call.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, DE, FL, GA, IL, IN, LA, MD, MA, MI, NJ, NY, NC, ND, OH, OR, PA, SD, TN, TX, WA
Page updated: Jan 10, 2026