medical Class II Updated 2019-05-15

Ortho-Clinical Diagnostics recalls VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 192

Recalled Product

VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 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: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979 30005981 through 30005991 30005993, 30005994 30006000 through 30006005 UDI: 10758750000272
View official government recall

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