The Recall Desk
HighFDA (Devices)·Z-1022-2022·Announced 2022-05-11

Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results

Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.

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 is an FDA Class II recall with no reported illnesses or injuries. The hazard—falsely elevated diagnostic results—constitutes a risk-of-harm product where patient injury has not yet been reported, warranting a High severity rating.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Enhanced Estradiol (eE2) (REF) 500T in vitro diagnostic test kits (all lot numbers) used to measure estradiol levels in laboratory specimens.

The product has been found to produce falsely elevated results when testing plasma specimens. These inaccurate readings could lead clinicians to misinterpret patient test results and potentially affect clinical decision-making.

This recall affects 230 units distributed worldwide, including the United States and numerous international locations.

Healthcare facilities and laboratories using this product should discontinue use immediately and contact Siemens Healthcare Diagnostics for replacement or further guidance.

The recalled product

Product
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • false-elevation
  • inaccurate-results

Distribution

Distributed nationwide across the United States.

Related recalls

Same category