Agency classClass IIOur severity:High FDA (Devices)·Z-1020-2022·Announced 2022-05-11

Estradiol diagnostic test kits recalled for falsely elevated results

Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 in vitro diagnostic device recall with potential to produce inaccurate test results that could affect clinical decision-making. Although no illnesses or injuries are reported in the source, the defect presents a risk of patient harm through misinterpretation of critical hormone test measurements.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the Atellica IM Enhanced Estradiol (eE2) 100T diagnostic test kits due to their potential to produce falsely elevated results when testing plasma specimens. This defect could lead clinicians to misinterpret patient results.

The affected test kits were distributed worldwide, including throughout the United States and numerous international markets in Europe, Asia, Africa, and the Middle East. All lot numbers containing the specified UDI codes are included in this recall, with approximately 2,044 units affected.

Healthcare facilities and laboratories currently using these test kits should contact Siemens Healthcare Diagnostics for replacement or return instructions. Facilities should review their procedures and consider the appropriateness of retesting patients whose results were obtained with these kits, as falsely elevated hormone measurements could impact clinical decision-making.

The recalled product

Product: Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In vitro diagnostics
Hazard: falsely-elevated-results
diagnostic-error
Affected units: 2,044

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · falsely elevated results