The Recall Desk
HighFDA (Devices)·Z-1504-2023·Announced 2023-05-10

Siemens Atellica cortisol kits recalled for negative bias in urine testing

Siemens Healthcare Diagnostics recalls 34,746 Atellica IM Cortisol diagnostic kits due to negative bias in urine test results, which may produce inaccurately low cortisol measurements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for diagnostic measurement inaccuracy. The negative bias in urine cortisol test results represents a risk of misdiagnosis and potential incorrect clinical decisions, though no reported illnesses or injuries have been documented.

Plain-English summary

Siemens Healthcare Diagnostics is recalling 34,746 Atellica IM Cortisol diagnostic kits (models 50T, 250T, and REF 250T) due to negative bias in cortisol measurements. The kits are in vitro diagnostic devices used to quantitatively measure cortisol in human serum, plasma, and urine samples.

The affected kits exhibit a negative bias when measuring urine cortisol levels. Specifically, urine quality control (QC) test results intermittently fall out of range on the low side, producing results lower than the actual cortisol concentration. This inaccuracy could lead to misinterpretation of patient cortisol levels.

The recalled kits have been distributed worldwide, including throughout the United States. Specific lot numbers have been identified for each model variant (50T, 250T, and REF 250T), with Universal Device Identifiers (UDIs) provided to facilitate identification of affected inventory.

The recalled product

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.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In vitro Diagnostic
Hazard
  • measurement-bias
  • inaccurate-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distributed nationwide across the United States.

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