Beckman Coulter Uric Acid Reagent Recalled for False Low Results
Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.
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 is a diagnostic error (false low results) rather than a direct physical injury or contamination, fitting the criteria for moderate severity involving potential adverse health consequences through misdiagnosis.
Plain-English summary
Beckman Coulter Inc. is recalling Uric Acid, Catalog No. OSR6x98, a system reagent intended for the quantitative determination of uric acid in human serum, heparinized plasma, and urine on Beckman Coulter AU analyzers. The recall affects all lots of the product.
The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Uric Acid assay. This issue is part of a broader identification affecting several other assays, including Cholesterol, Triglyceride, Lactate, and Lipase.
A total of 59,401 units were distributed worldwide, with 10,868 units distributed in the United States, including Puerto Rico. The product was also distributed to numerous countries across the globe. Users of the product should be aware that Dipyrone may interfere with the accuracy of the test results.
The recalled product
- Product
- Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
- 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
Part of a larger recall action
This product is one of 5 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 5 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 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- ModerateBeckman Coulter Recalls Uric Acid Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- HighBeckman Coulter Uric Acid Assay Recalled Due to Interference
FDA (Devices) · 2019-10-30
- ModerateBeckman Coulter Uric Acid Assay Recalled Due to NAC Interference
FDA (Devices) · 2015-02-04
- ModerateBeckman Coulter Recalls Creatinine Reagents for Calibration Instructions
FDA (Devices) · 2013-03-27
- ModerateBeckman Coulter Recalls UIBC Reagent Lot 2690 Due to Erroneous Results
FDA (Devices) · 2020-10-07
- ModerateBeckman Coulter Recalls Triglycerides Reagent Due to Interference
FDA (Devices) · 2017-05-24