Fujifilm Medical Systems U.S.A., Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Lot EL629, Model 990-28011
Products Sold
Lot EL629, Model 990-28011
Fujifilm Medical Systems U.S.A., Inc. is recalling Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LD due to FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On, 12/22/2020, FUJIFILM issued an Urgent Medical Device Removal notice to customers via email. Incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result in incorrect results when used in testing.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026