Recall Z-0163-2016— Abbott Laboratories, Inc

Name: FDA recall Z-0163-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-09

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2015-09-09, terminated 2016-11-17. It names one FDA 510(k) clearance: K980367. Product: ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.. Reason: Incorrect tubing..

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-09
Terminated: 2016-11-17
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 i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.

Reason for recall

Incorrect tubing.

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