Abbott Laboratories, Inc recalls ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park,…

Recall date

January 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0011-2018

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croat…

Why it was recalled

There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.