Abbott Laboratories, Inc recalls ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemi…

Recall date

September 29, 2017

Source

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

Recall number

Z-0165-2018

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

Worldwide distribution to US, Canada, France, and Germany.

Why it was recalled

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

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 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.