Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots

Is my product affected?

ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots

• UPC 00630414591056

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

What happened

Siemens Healthcare Diagnostics is recalling the ADVIA Centaur Enhanced Estradiol (eE2) test kit (all lots, serial number 10697757) used to measure estradiol levels in patient blood samples. The test can produce falsely elevated results when used with plasma specimens, which could cause clinicians to misinterpret patient test results. The product was distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, Africa, and the Middle East, with 88 units affected across multiple lot numbers.

The recall notice does not specify a remedy or action that affected consumers should take.

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: 88 units Lot/code info: All lot numbers UDI: (01)00630414591056(10)13852076(17)20220115 (01)00630414591056(10)46894074(17)20211028 (01)00630414591056(10)89042083(17)20220805

Source

Official record: FDA (Device enforcement) ↗

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

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