HIGH

Beckman Coulter Phosphorus Reagent Recall: 2,146 Units for Calibration Failures

Beckman Coulter recalled 2,146 units of the SYNCHRON Systems Phosphorus (PHOSm) Reagent due to calibration failures that may delay patient results. Specific reagent lots may not function properly before their expiration date. Healthcare providers and patients must stop using these reagents immediately and follow manufacturer instructions.

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

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

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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

  1. Check the lot numbers against the recalled list: M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, M412278.
  2. Verify the UDI number, 15099590233358, on the packaging.
  3. 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.

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

  • 2146 units recalled
  • Affected lots: REF 467868, multiple lot numbers
  • Calibration failure leads to delays in patient results
  • Distribution includes multiple US states, Canada, Mexico, and Singapore
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeDiagnostic Reagent
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI: 15099590233358
Lot Numbers: M309642
M309641
M401490
M404365
+6 more
Affected States
Nationwide
Report Date
October 15, 2025
Recall Status
ACTIVE

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