Medical device recalls Moderate risk

Beckman Coulter Inc. recalls Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687

Recall date
May 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2638-2017
FDA classification
Class II
Brand / firm
Beckman Coulter Inc.
Sold / distributed
Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Ge…

Why it was recalled

The Access immunoassays are susceptible to biotin interference.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687

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