Z-1419-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- January 4, 2017
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1148
Product Description
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
Reason for Recall
DHEA-S causes falsely elevated progesterone results.
Distribution Pattern
US Nationwide distribution including Puerto Rico
Code Information
16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA