FDA Device recall Z-1419-2017
Dimension Vista LOCI Progesterone
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of Dimension Vista LOCI Progesterone by Siemens Healthcare Diagnostics, citing DHEA-S causes falsely elevated progesterone results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-04 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
Reason
DHEA-S causes falsely elevated progesterone results.
Identifiers
| code_info | 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2017%22
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