Beckman Coulter Recalls Salicylate Reagent Due to Drug Interference
Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.
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. The hazard involves potential diagnostic errors (false low results) due to drug interference, which fits the criteria for moderate severity involving low-risk contamination or labeling/functional issues without reported serious injuries.
Plain-English summary
Beckman Coulter Inc. is recalling Salicylate Reagent (SALY 2 x 45), Catalog No. 378194, which is intended for the quantitative determination of salicylate concentration in human serum or plasma. The recall covers all lots of the product.
The recall was initiated because Beckman Coulter identified that the drugs Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine may act as potential sources of interference. The presence of these drugs may result in false low results when using the reagent.
The product was distributed worldwide, including in the United States and Puerto Rico. A total of 50,645 units were distributed, with 43,816 units in the US. Users should stop using the product and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in 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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