Medical device recalls Moderate risk

Abbott Laboratories, Inc recalls ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system…

Recall date
September 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0163-2016
FDA classification
Class II
Brand / firm
Abbott Laboratories, Inc
Sold / distributed
Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan

Why it was recalled

Incorrect tubing.

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 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.

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