Device product
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Z-1024-2022
Product summary
- Event
- Event 89953
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 952 units
- Official record key
device-enforcement:Z-1024-2022
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)00630414574646(10)14530079(17)20220304 (01)00630414574646(10)53553079(17)20220304 (01)00630414574646(10)54118081(17)20220521 (01)00630414574646(10)62860081(17)20220521 (01)00630414574646(10)70552083(17)20220805 (01)00630414574646(10)76807076(17)20220115 (01)00630414574646(10)93281076(17)20220115
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
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results