Fujifilm Medical Systems U.S.A., Inc. recalls Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
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