Beckman Coulter recalled 36,981 bicarbonate reagents on October 14, 2025. The reagent may produce falsely high bicarbonate results due to interference from Lactate Dehydrogenase. Healthcare providers and patients must stop using it immediately.
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Ireland, Inc. or your healthcare provider for instructions. Notification method: Letter
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Beckman Coulter bicarbonate reagents are used in clinical laboratories for the quantitative determination of bicarbonate levels in human serum and plasma. These reagents help in diagnosing and monitoring various medical conditions.
The bicarbonate reagent can generate falsely high results due to interference from Lactate Dehydrogenase in the test sample, which can mislead healthcare providers regarding a patient's bicarbonate levels.
This recall is not part of a broader industry pattern.
This recall could lead to significant inconveniences in clinical settings, as healthcare providers will need to find alternate testing methods, potentially delaying diagnoses.
Lot numbers and catalog numbers can typically be found on the product packaging or accompanying documentation.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep receipts and records of the product purchase and any correspondence regarding the recall for your records.
The recalled bicarbonate reagents include catalog numbers OSR6137, OSR6237, and OSR6637. These products were distributed worldwide, including across all U.S. states and countries such as Canada and Brazil. The quantity recalled is 36,981 reagents.
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