Device product

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

Z-1022-2022

March 03, 2022

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 89953
Status: Ongoing
Classification: Class II
Quantity: 230 units
Official record key: device-enforcement:Z-1022-2022

Official wording

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

Code information: All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303

Distribution pattern: 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, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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