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

Recall number

Z-1741-2020

Recalling firm

Beckman Coulter Inc.

Product

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

Status

Terminated

Initiated

2019-05-17

Posted

not on file

Terminated

2022-03-11

Reason

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

Root cause

Software design

Action

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.

Quantity

291 units

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K140496"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2050012

Firm city

Brea

Firm state

CA

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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