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.
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, 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · false low results
See all →- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- ModerateBeckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls Uric Acid Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Lipase Reagent Recalled for Potential False Low Results
FDA (Devices) · 2016-06-15
Similar recalls
- ModerateBeckman Coulter Lactate Reagent Recalled for Potential False Low Results
FDA (Devices) · 2016-06-15
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Error Messages
FDA (Devices) · 2013-06-05
- ModerateBeckman Coulter Lactate Assay Recalled Due to NAC Interference
FDA (Devices) · 2015-02-04
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Calibration Failures
FDA (Devices) · 2013-07-03
- ModerateBeckman Coulter Lipase Reagent Recalled for Potential False Low Results
FDA (Devices) · 2016-06-15
- ModerateBeckman Coulter Uric Acid Reagent Recalled for False Low Results
FDA (Devices) · 2016-06-15