Z-1741-2020Class II

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

Name: Z-1741-2020 Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power...
Creator: Beckman Coulter Inc.
Published: 2019-05-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-05-17 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352 on 2019-05-17. FDA classified it as Class II and gives the reason as "Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1741-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-17
Posted: 2020-04-17
Terminated: 2022-03-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1741-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1741-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code JJE

K140496Class IIAccess Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsBeckman Coulter, Inc. / cleared 2014-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)