FDA-Device2017-03-15Class II
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
Siemens Healthcare Diagnostics, Inc
Hazard
DHEA-S causes falsely elevated progesterone results.
Sold states
US Nationwide distribution including Puerto Rico
Affected count
1148
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1419-2017Don't want to check this manually?
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