Siemens Healthcare Diagnostics, Inc.: Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quan

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: 34,746 kits Lot/code info: Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher; Atellica IM Cortisol 250T UDI-DI: 00630414598642; Kit Lot Numbers: 50734343 88974345 29105347 and higher; Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608; Kit Lot Numbers: 53842343 58039343 94430345 and higher

UPC codes

00630414598659, 00630414598642, 00630414293608

Source

Official record: FDA (Device enforcement) ↗

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