Recall Z-1504-2023 ยท JFT Fluorometric, Cortisol
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 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 | 34,746 kits |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142723 | ADVIA Centaur Cortisol (COR) Assy Siemens Healthcare Diagnostics, Inc., Mar 31, 2015 |