Recall Z-1741-2020— Beckman Coulter Inc.

Name: FDA recall Z-1741-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-17

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-05-17, terminated 2022-03-11. It names one FDA 510(k) clearance: K140496. Product: Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.. 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: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-17
Terminated: 2022-03-11
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140496 — Access 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.