Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and…

Recall date

March 20, 2015

Source

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

Recall number

Z-1946-2015

FDA classification

Class II

Brand / firm

Axis-Shield Diagnostics, Ltd.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

Why it was recalled

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

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

What was recalled

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.