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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
Recalled July 8, 2015 · FDA recall Z-1946-2015 · Axis-Shield Diagnostics
Hazard
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. · FDA Class II
Units
52 kits + 75 kits Beckman Coulter Brand OUS
Sold at
Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
Description
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Product
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.
Manufacturer(s)
Axis-Shield Diagnostics, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →