FDA recall Z-1741-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2019-05-17

Report date

2020-04-29

Termination date

2022-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1741-2020