Beckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference
Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, but the hazard is limited to potential false low results due to drug interference rather than direct physical injury or contamination, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Beckman Coulter Inc. is recalling HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. This product is intended for the quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
The recall was initiated because the company identified Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine as potential sources of interference. The presence of these drugs may result in false low results when using the reagent.
A total of 91,996 units were distributed worldwide, with 51,027 units distributed in the United States. The recall covers all lots of the product. Users should stop using the product and contact Beckman Coulter for further instructions.
The recalled product
- Product
- HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- all lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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