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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