Medical device recalls Moderate risk

Beckman Coulter Inc. recalls Access Thyroglobulin, A34085G, Catalog No. 33860

Recall date
May 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2636-2017
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 Thyroglobulin, A34085G, Catalog No. 33860

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