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Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement
Recalled May 10, 2023 · FDA recall Z-1555-2023 · Ortho-Clinical Diagnostics
Hazard
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 · FDA Class II
Units
2001 units
Sold at
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
Description
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
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →