The Recall Desk
HighFDA (Devices)·Z-1505-2023·Announced 2023-05-10

Siemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias

Siemens Healthcare Diagnostics is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits due to negative bias in urine samples causing intermittently low test results that could affect clinical diagnosis.

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: This FDA Class II device has a technical measurement issue that could compromise diagnostic accuracy, representing a risk-of-harm to patients. No illnesses or injuries have been reported, which places it at the High severity level per the rubric for risk-of-harm products without documented injury.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 18,961 ADVIA Centaur Cortisol diagnostic kits. The recalled products are used to measure cortisol in human serum, plasma, and urine samples. The three affected variants are ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927).

The kits exhibit a negative bias when testing urine patient samples, causing cortisol Quality Control results to intermittently fall below the acceptable range. This measurement inaccuracy could result in incorrect test findings that may affect clinical diagnosis and treatment decisions.

The kits have been distributed worldwide and throughout the United States. Affected lot numbers are detailed in the FDA recall notice. Healthcare facilities using these kits should verify their lot numbers against the affected batches and contact Siemens Healthcare Diagnostics for remediation guidance.

The recalled product

Product
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and li
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • measurement-bias
  • diagnostic-error

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)

  • ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943
  • Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher
  • ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950
  • Kit Lot Numbers: 49742344 88319346 29108348 and higher
  • ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659
  • Kit Lot Numbers: 75474344 11352346 and higher

Distribution

Distributed nationwide across the United States.

Related recalls

Same category