Device 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

Z-1557-2023

March 10, 2023

Class II

Product summary

Firm: Ortho-Clinical Diagnostics, Inc.
Event: Event 92055
Status: Ongoing
Classification: Class II
Quantity: 1148 units
Official record key: device-enforcement:Z-1557-2023

Official wording

Reason: 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

Code information: UDI: 10758750007110 Serial Number Range: J56000147- J56003653

Distribution pattern: Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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