Siemens Healthcare Diagnostics, Inc. Recall 92059
Description: 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.
Siemens Healthcare Diagnostics, Inc. Recall 92059 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1504-2023 |
| Event ID | 92059 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| Quantity | 34,746 kits |
| Recall Reason | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| Device Classification | 20230510 |
| Device 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 |
| Center Classification Date | 20230503 |
| Recall Initiation Date | 20230316 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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