Skip to content
Recall Observatory FDA recall evidence

Device product

Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.

Z-1741-2020

May 17, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 84918
Status
Terminated
Classification
Class II
Quantity
291 units
Official record key
device-enforcement:Z-1741-2020

Official wording

Reason: Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.

Code information: 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.

Distribution pattern: Distribution was made to AL, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, MI, NC, ND, NJ, NY, OH, OR, PA, SD, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Australia, Canada, China, Czech Republic, Egypt, France, Germany, India, Italy, Republic of Korea, Kuwait, Malaysia, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey, UAE, United Kingdom, and Viet Nam.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software design problem