Device product
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
Z-1505-2023
Product summary
- Event
- Event 92059
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,961 kits
- Official record key
device-enforcement:Z-1505-2023
Official wording
Reason: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Code information: ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.