Recall Z-0165-2018— Abbott Laboratories, Inc

Name: FDA recall Z-0165-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-29

Class II · Completed

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2017-09-29. It names one FDA 510(k) clearance: K980367. Product: ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.. Reason: 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..

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Completed
Initiated: 2017-09-29
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K980367 — AEROSET SYSTEMAbbott Laboratories·cleared 1998-04-01

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

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

Reason for recall

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.

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