Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM Enhanced Estradiol (eE2) test kit (all lot numbers) used to measure estradiol levels in blood samples. The test kits, totaling 230 units, were distributed worldwide including across the United States and numerous countries in Europe, Asia, Africa, and South America. The recall was initiated because the test kits produced falsely elevated results when used with plasma specimens, which could cause clinicians to misinterpret patient test results.
The FDA record 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.
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: 230 units Lot/code info: All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.