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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter Ireland
- Product type
- Bicarbonate Reagent
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 14, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check your bicarbonate reagent for catalog numbers OSR6137, OSR6237, or OSR6637.
- Verify the lot numbers against the recalled list: 2681-2696, 2702-2716, 2726-2739.
- 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.
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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.
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
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Safety Guide
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