Fujifilm Medical Systems U.S.A., Inc. recalls Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determi…

Recall date

December 22, 2020

Source

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

Recall number

Z-0932-2021

FDA classification

Class III

Brand / firm

Fujifilm Medical Systems U.S.A., Inc.

Sold / distributed

US Nationwide distribution including in the states of MO, OR, MD, PA.

Why it was recalled

FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.