Beckman Coulter Phosphorus Reagents Recalled for Calibration Failure

Agency Publication Date: October 8, 2025

Summary

Beckman Coulter Inc. is recalling 2,146 units of SYNCHRON Systems Phosphorus (PHOSm) Reagent (REF 467868). Specific lots of this reagent may fail to calibrate correctly before their expiration date, leading to delays in obtaining patient lab results. This product is used in medical laboratories for diagnostic testing.

Risk

When reagent lots fail calibration, laboratories cannot produce accurate or timely patient results, which may delay clinical diagnosis or medical treatment decisions.

What You Should Do

This recall involves SYNCHRON Systems Phosphorus (PHOSm) Reagent sold under the Beckman Coulter brand, identified by reference number 467868.
Identify affected products by checking the lot number and UDI (Unique Device Identifier) on the reagent packaging. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact Beckman Coulter Inc. or your distributor to arrange for a return, replacement, or corrective action for your inventory.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SYNCHRON Systems Phosphorus (PHOSm) Reagent

Variants: In Vitro Diagnostic Use, Rx Only

Model / REF:

467868

Lot Numbers:

M309642

M309641

M401490

M404365

M406380

M406417

M408408

M410466

M410513

M412278

UDI:

15099590233358

Quantity: 2146 units; Recall #: Z-0071-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97590

Status: Active

Manufacturer: Beckman Coulter Inc.

Sold By: Hospitals; Diagnostic Laboratories; Medical Facilities

Manufactured In: United States

Units Affected: 2146 units

Distributed To: Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves SYNCHRON Systems Phosphorus (PHOSm) Reagent sold under the Beckman Coulter brand, identified by reference number 467868.

Identify affected products by checking the lot number and UDI (Unique Device Identifier) on the reagent packaging. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact Beckman Coulter Inc. or your distributor to arrange for a return, replacement, or corrective action for your inventory.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97590

Status: Active

Manufacturer: Beckman Coulter Inc.

Sold By: Hospitals; Diagnostic Laboratories; Medical Facilities

Manufactured In: United States

Units Affected: 2146 units

Distributed To: Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington, West Virginia