Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling the Atellica IM Enhanced Estradiol (eE2) 100T test kit used to measure estradiol levels in blood samples. The recall affects 2,044 units distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, Africa, and other regions. The problem is that the test can produce falsely elevated results when used with plasma specimens, which could cause clinicians to misinterpret patient test results.
The recall involves all lot numbers of this product. According to the recall record provided, no specific remedy or consumer action is specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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: 2,044 units Lot/code info: All lot numbers UDI: (01)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.