Fujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error
Fujifilm is recalling Wako HDL-C/LDL-C Calibrator Lot EL629 because incorrect concentration values were printed on the bottle labels, which may result in incorrect testing results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a labeling error that may lead to incorrect test results, fitting the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling Wako HDL-C/LDL-C Calibrator, Lot EL629, Model 990-28011. The product is 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.
The recall was initiated because incorrect concentration values were printed on the bottle labels for all product manufactured as part of Lot EL629. This labeling error may result in incorrect results when the calibrator is used in testing.
The affected product was distributed nationwide in the United States, including in the states of Missouri, Oregon, Maryland, and Pennsylvania. The recall quantity is 10 boxes, containing 4 units per box. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- 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
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot EL629
- Model 990-28011
Distribution
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