HIGH

Beckman Coulter Recalls Bicarbonate Reagent Over High Result Risk

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.

Quick Facts at a Glance

Recall Date
October 14, 2025
Hazard Level
HIGH
Brand
Beckman Coulter Ireland
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

What You Should Do

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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Product Details

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 Hazard

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.

What to Do

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.

Contact Information

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.

Key Facts

  • Recalled on October 14, 2025
  • Total quantity: 36,981 reagents
  • Potential for falsely high bicarbonate results
  • Affected catalog numbers: OSR6137, OSR6237, OSR6637
  • Contact Beckman Coulter for further instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeBicarbonate Reagent
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2693 2694 2695 2696 OSR6237 - 15099590010348 Lot Numbers: 2702 2703 2704 2705 2706 2707 2708 2709 2710 2712 2713 2714 2715 2716 OSR6637 - 15099590060206 Lot Numbers: 2726 2728 2729 2730 2731 2732 2733 2734 2736 2737 2738 2739
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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