Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Recalled by Beckman Coulter Inc. Due to Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF...

Date: September 3, 2025
Company: Beckman Coulter Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.

Affected Products

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

Quantity: 2146 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 15 states: AL, KY, LA, MD, MA, MS, NE, NJ, NY, NC, OK, PA, TX, WA, WV

Affected (15 states)Not affected

About Beckman Coulter Inc.

Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report