Beckman Coulter Recalls Enzymatic Creatinine Reagent Due to Interference
Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.
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. This aligns with the rubric for moderate severity involving labeling or performance issues without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. This product is intended for the quantitative determination of creatinine concentration in human serum, plasma, or urine. The recall involves 12,665 units total, with 1,399 units distributed in the United States.
The recall was initiated because Beckman Coulter identified that the drugs Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine can act as potential sources of interference. The presence of these drugs may result in false low creatinine results. The recall covers all lots of the product.
The product was distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East. Users of the product should be aware that the presence of the specified interfering drugs may compromise the accuracy of the test results.
The recalled product
- Product
- Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
- 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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