Beckman Coulter Recalls Lactate Reagent Due to Interference from Specific Drugs
Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is limited to potential false low results due to drug interference, without reported injuries or deaths.
Plain-English summary
Beckman Coulter Inc. is recalling Lactate Reagent (LACT 2 x 50), Catalog No. A95550. This product is intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF). The recall involves 92,837 units total, with 71,271 units distributed in the United States. The product was distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East.
The recall was initiated because Beckman Coulter identified that specific drugs can act as potential sources of interference with the reagent. The drugs identified are Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine. The presence of these substances may result in false low results when measuring Lactate concentration.
Healthcare facilities and laboratories that have purchased or are using this product should stop using it and contact Beckman Coulter for further instructions. Users should be aware that the presence of the specified drugs in patient samples may lead to inaccurate test results.
The recalled product
- Product
- Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
- 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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