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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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.
The bicarbonate reagent can generate falsely high bicarbonate results in test samples. This interference with Lactate Dehydrogenase (LDH) presents a significant risk to patient safety, potentially leading to incorrect diagnoses.
No specific incidents or injuries have been reported related to this recall. However, the potential for misdiagnosis poses a serious health risk.
Stop using the bicarbonate reagent immediately. Follow the recall instructions from Beckman Coulter. Contact Beckman Coulter Ireland, Inc. or your healthcare provider for further guidance.
For more details, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0997-2026 or contact Beckman Coulter directly.
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