Recall Z-1505-2023 ยท JFT Fluorometric, Cortisol
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 Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
| Date | May 3, 2023 (initiated Mar 16, 2023) |
| Status | Open, Classified |
| Reason | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions to be Taken by the Customer Discontinue use of urine patient samples with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays until further notice. Customers may continue to use serum and plasma sample types with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness |
| Quantity | 18,961 kits |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962559 | ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp., Nov 5, 1996 |