FDA-Device2016-10-05Class II
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Siemens Healthcare Diagnostics, Inc
Hazard
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Sold states
Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa
Affected count
2,248 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2899-2016Don't want to check this manually?
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