FDA-Device2025-10-15Class II
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
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-0071-2026Want us to check the next one for you?
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