Siemens Healthcare Diagnostics, Inc.: Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

Is my product affected?

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

• UPC 00630414598864

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling the Atellica IM Enhanced Estradiol (eE2) 500T, an in vitro diagnostic device used to measure estradiol levels in patient samples. The recall affects 374 units distributed worldwide, including across the United States and numerous countries in Europe, Asia, Africa, and other regions. All lot numbers of this product are included in the recall.

The device can produce falsely elevated results when testing plasma specimens, which could cause clinicians to misinterpret patient test results. The recall record does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Details from the source

Reason for recall: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Rus Quantity: 374 units Lot/code info: All lot numbers UDI: 01)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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