Z-1741-2020 Class II Terminated
FDA device recall Z-1741-2020 was initiated by Beckman Coulter Inc. on May 17, 2019 and is designated Class II. 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. The recall status is terminated (terminated March 11, 2022). Affected quantity: 291 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- May 17, 2019
- Termination Date
- March 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 units
Product Description
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
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.
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.
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.