Beckman Coulter Inc. recalls Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C

Recall date

March 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1833-2017

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland,…

Why it was recalled

Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

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 Ferritin Calibrators, Part No. 33025, Ref No. B50136C