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Recall Observatory FDA recall evidence

Device 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.

Z-1504-2023

March 16, 2023

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 92059
Status
Ongoing
Classification
Class II
Quantity
34,746 kits
Official record key
device-enforcement:Z-1504-2023

Official wording

Reason: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.