Ortho-Clinical Diagnostics: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

Agency Publication Date: May 6, 2019

Affected Products

Product: VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 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

Serial Numbers: 56003270 & above UDI: 10758750002740

Product: VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 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

Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI: 10758750007110

Product: VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 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

Serial Numbers: 36001160 & above UDI: 10758750002979)

Product: VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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

Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI:10758750007103

Product: VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 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

Serial Numbers: 76000108 & above UDI: 1075870031610

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

Serial Numbers: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979 30005981 through 30005991 30005993, 30005994 30006000 through 30006005 UDI: 10758750000272

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

Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82311

Status: Resolved

Manufacturer: Ortho-Clinical Diagnostics

Manufactured In: United States

Units Affected: 7 products (55 units; 4 units; 267 units; 28 UNITS; 62 units; 45 units; 25 units)

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Sources: FDA iRES · Raw API Response

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