Abbott Laboratories recalls ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagno…

Recall date

June 11, 2015

Source

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

Recall number

Z-2202-2015

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

US Nationwide Distribution in the states of CA, AL, NY and WI.

Why it was recalled

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

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 c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.