Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type...
FDA Recall #Z-0932-2021 — Class III — December 22, 2020
Product Description
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.
Reason for Recall
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.
Recalling Firm
Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
10 boxes (4 units per box)
Distribution
US Nationwide distribution including in the states of MO, OR, MD, PA.
Code Information
Lot EL629, Model 990-28011
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated