Home / Recalls / Medical Devices
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 determin
Recalled February 3, 2021 · FDA recall Z-0932-2021 · Fujifilm Medical Systems U.S.A
Hazard
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. · FDA Class III
Units
10 boxes (4 units per box)
Sold at
US Nationwide distribution including in the states of MO, OR, MD, PA.
Description
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.
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.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →