Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to FUJIFILM has become aware that incorrect concentration values...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.
Affected Products
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.
Quantity: 10 boxes (4 units per box)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report