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

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.

On September 3, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via E-Mail. Beckman Coulter asked consignees to take the following actions: 1. You may continue to use the affected lots if calibration passes and quality control results are within your facility s acceptance criteria. 2. If the above lots fail calibration due to INIT ADC HI before the lot expiration date, contact Customer Technical Support Center for troubleshooting and/or replacement. 3. If you receive replacement product, review the Safety Data Sheet (SDS) and discard the affected lot(s). 4. Beckman Coulter offers SYNCHRON Systems Cartridge Chemistry Phosphorus (PHS REF A09426) Reagent as an alternative. 5. Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 6. Please respond within 10 days.

• FDA enforcement recordOfficial FDA database entry for Z-0071-2026
• FDA device classification · CEOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1580The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.