FDAFDA · Food and drugs·Recall number Z-1419-2017
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
Published March 15, 2017 · Recall initiated: January 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
DHEA-S causes falsely elevated progesterone results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- US Nationwide distribution including Puerto Rico
- Lot
- 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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