Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Numbe

Hazard

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Details from the source

Reason for recall: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. Distribution: Worldwide distribution - US Nationwide. Quantity: 18,961 kits Lot/code info: 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

UPC codes

00630414602943, 00630414602950, 00630414598659

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.