Class II
Medical Device Recall: SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Beckman Coulter Inc. · September 3, 2025
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.
Distribution
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
States Affected
AL, KY, LA, MA, MD, MS, NC, NE, NJ, NY, OK, PA, TX, WA, WV
Quantity Affected
2146 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0071-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.