Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1557-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 10, 2023

Date Posted: May 10, 2023

Recall Number: Z-1557-2023

Event ID: 92055

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1148 units

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

Voluntary or Mandated:

Voluntary: Firm initiated