Device product
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
Z-1419-2017
Product summary
- Event
- Event 76212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1148
- Official record key
device-enforcement:Z-1419-2017
Official wording
Reason: DHEA-S causes falsely elevated progesterone results.
Code information: 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA
Distribution pattern: US Nationwide distribution including Puerto Rico
Derived failure modes
-
Unknown
DHEA-S causes falsely elevated progesterone results.