Devices

Device Recall VIDAS Estradiol II (E2 II)

Model / Serial
Lots 1005081700, 1005172850 & 1005359170
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
Product Description
VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Manufacturer
BioMerieux SA
1 Event
- Recall of Device Recall VIDAS Estradiol II (E2 II)

Manufacturer

BioMerieux SA

Manufacturer Address
BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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