Ortho-Clinical Diagnostics, Inc.: MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

Agency Publication Date: May 4, 2023

Affected Products

Product: VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6844461

UDI: 10758750031610 Serial Number Range: J76000109- J76001492

Product: VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413

UDI: 10758750002740 Serial Number Range: J56000143- J56004477

Product: VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802915

UDI: 10758750007110 Serial Number Range: J56000147- J56003653

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92055

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, Inc.

Manufactured In: United States

Units Affected: 3 products (2001 units; 4895 units; 1148 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI: 10758750031610 Serial Number Range: J76000109- J76001492

UDI: 10758750002740 Serial Number Range: J56000143- J56004477

UDI: 10758750007110 Serial Number Range: J56000147- J56003653