Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots

Is my product affected?

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots

• UPC 00630414573342

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

What happened

Siemens Healthcare Diagnostics is recalling all lots of the ADVIA Centaur Enhanced Estradiol (eE2) 100T test kit, a device used to measure estradiol levels in blood samples. The recall affects 2,315 units distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, Africa, and the Middle East. The reason for the recall is that the test produces falsely elevated results when used with plasma specimens, which could cause clinicians to misinterpret patient test results.

The recall covers eight specific lot numbers with varying expiration dates ranging from August 2021 to August 2022. The source document does not specify what actions affected consumers or healthcare providers should take in response to this recall.

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: 2,315 units Lot/code info: All lot numbers UDI: (01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115

Source

Official record: FDA (Device enforcement) ↗

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

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