Radioimmunoassay, Prolactin (lactogen)
Siemens Healthcare Diagnostics Inc.'s record for this product code
MDR events16All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
16 adverse event reports on file
- ATELLICA IM PROLACTIN (PRL)Dec 11, 2025Malfunction1219913-2025-00218
- ATELLICA IM PROLACTIN (PRL)Feb 17, 2023Malfunction1219913-2023-00025
- ATELLICA IM PROLACTIN (PRL)Jan 17, 2023Malfunction1219913-2023-00015
- ADVIA CENTAUR PROLACTIN (PRL)Nov 3, 2022Malfunction1219913-2022-00381
- ADVIA CENTAUR PROLACTIN (PRL)Nov 3, 2022Malfunction1219913-2022-00380
- ATELLICA IM PROLACTIN (PRL)Nov 4, 2021Malfunction1219913-2021-00476
- ATELLICA IM PROLACTIN (PRL)Nov 4, 2021Malfunction1219913-2021-00477
- ATELLICA IM PROLACTIN (PRL)Aug 20, 2021Malfunction1219913-2021-00422
- ATELLICA IM PROLACTIN (PRL)Mar 30, 2021Malfunction1219913-2021-00211
- ATELLICA IM PROLACTIN (PRL)Dec 4, 2020Malfunction1219913-2020-00592
Recalls
2 recall events for this product code
- TerminatedMay 5, 2017
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
View FDA record ↗ - TerminatedSep 19, 2012
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Siemens Healthcare Diagnostics Inc. under this product code.