FDA-Device2025-10-15Class II
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Beckman Coulter Inc.
Hazard
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.
Sold states
US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico Singapore
Affected count
2146 units
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2026Don't want to check this manually?
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