Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 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
- Product type
- Diagnostic Reagent
- Model numbers
- UDI: 15099590233358, Lot Numbers: M309642, M309641, M401490, M404365, M406380, M406417, M408408 +3 more
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
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 Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The SYNCHRON Systems Phosphorus (PHOSm) Reagent is used in medical laboratories for in vitro diagnostics. It assists in measuring phosphorus levels in patient samples, critical for various health assessments.
Why This Is Dangerous
Calibration failures can result in inaccurate phosphorus readings, potentially impacting patient diagnoses and treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The failure to obtain accurately calibrated results can delay necessary medical care, emphasizing the importance of immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Verify the UDI number, 15099590233358, on the packaging.
- Review any communication from Beckman Coulter regarding the recall.
Where to find product info
Lot numbers and UDI numbers are typically found on the outside packaging and product documentation.
What timeline to expect
Refunds or replacement timelines typically range from 4-6 weeks after the recall notification.
If the manufacturer is unresponsive
- Contact Beckman Coulter customer service directly via email or phone for follow-up inquiries.
- Document all attempts to contact the company and keep a record of communications.
How to prevent similar issues
- Always look for the latest recalls on medical devices before purchase.
- Check products for proper certification and compliance with health regulations.
- Review user feedback on accuracy and reliability for diagnostic reagents.
Documentation advice
Keep all receipts, product packaging, and correspondence related to the recall for your records.
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Product Details
- Product Name: SYNCHRON Systems Phosphorus (PHOSm) Reagent - Reference Number: REF 467868 - Lot Numbers: M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278 - Quantity: 2,146 units - Distribution: Available in AL, KY, LA, MA, MD, MS, NC, NE, NJ, NY, OK, PA, TX, WA, WV, Canada, Mexico, Singapore
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Affected lots: REF 467868, multiple lot numbers
- Calibration failure leads to delays in patient results
- Distribution includes multiple US states, Canada, Mexico, and Singapore
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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