Ortho-Clinical Diagnostics: Medical Device Recall in 2019 - (Recall #: Z-1222-2019)

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, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended 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 Classification:

Class II

Date Initiated: March 11, 2019

Date Posted: May 1, 2019

Recall Number: Z-1222-2019

Event ID: 82366

Reason for Recall:

One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.

Status: Terminated

Product Quantity: 80

Code Information:

Systems Running Software Version 3.4 & 3.4.1

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated