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

Recall date

September 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0071-2026

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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