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

FDA device recall Z-0071-2026 · posted 2025-10-08 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

CEO

Quantity affected

2146 units

Distribution

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

Date initiated

2025-09-03

Date posted

2025-10-08

Location

Brea, CA