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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About This Product

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.

Why This Is Dangerous

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.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall could lead to significant inconveniences in clinical settings, as healthcare providers will need to find alternate testing methods, potentially delaying diagnoses.

Practical Guidance

How to identify if yours is affected

  1. Check your bicarbonate reagent for catalog numbers OSR6137, OSR6237, or OSR6637.
  2. Verify the lot numbers against the recalled list: 2681-2696, 2702-2716, 2726-2739.
  3. Stop using the reagent immediately if it matches the recalled items.

Where to find product info

Lot numbers and catalog numbers can typically be found on the product packaging or accompanying documentation.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document your communications with Beckman Coulter.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if necessary.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Ensure proper training for staff on the use of clinical reagents.
  • Regularly review product information for updates and safety notices.

Documentation advice

Keep receipts and records of the product purchase and any correspondence regarding the recall for your records.

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.

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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