Recall Z-0071-2026— Beckman Coulter Inc.

Name: FDA recall Z-0071-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-03

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2025-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.. Reason: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-03
Firm location: Brea, CA, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.