—#216039

Product

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

FDA product code: CEO — Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI: 15099590233358/ Lot Numbers: M309642 M309641 M401490 M404365 M406380 M406417 M408408 M410466 M410513 M412278

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2025-09-03
Posted by FDA: 2025-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.