medical Class II Updated 2019-05-15

Ortho-Clinical Diagnostics recalls VITROS ECi Immunodiagnostic System Refurbished Product Code

Recalled Product

VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Hazard / Issue

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040
View official government recall

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