FDA Device recall Z-1504-2023
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248)
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248) by Siemens Healthcare Diagnostics, citing there is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1504-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-16 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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.
Reason
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Identifiers
| code_info | Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and hi…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1504-2023%22
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