Recall – Software error causes excessive speed resulting in biohazard exposure

Company: Beckman Coulter Inc.
Date of Enforcement Report: 4/29/2020
Class II

PRODUCT

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

Recall Number: Z-1741-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Beckman Coulter Inc. on 5/17/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

291 units

DISTRIBUTION

US Nationwide and International

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
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Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.