FDA recall Z-1556-2023

Ortho-Clinical Diagnostics, Inc. · Class II · device

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

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-03-10
Report date: 2023-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2023