Ortho-Clinical Diagnostics: Medical Device Recall in 2019 - (Recall #: Z-1364-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

Product Classification:

Class II

Date Initiated: March 20, 2019

Date Posted: May 29, 2019

Recall Number: Z-1364-2019

Event ID: 82561

Reason for Recall:

Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported

Status: Terminated

Product Quantity: 85 units: US=19;OUS=66

Code Information:

Serial Number 76000108 thru current.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines

Voluntary or Mandated:

Voluntary: Firm initiated