Devices

Device Recall VITROS ECi Immunodiagnostic System

Model / Serial
Serial Numbers between 30000127 and 30002743. All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but Total B-hCG is not processed on all systems worldwide.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product Description
VITROS¿ ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS¿ ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. || Product Usage: || For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS ECi Immunodiagnostic System

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
Source
USFDA

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