Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1222-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

VITROS XT7600 Integrated System

Product Classification:

Class II

Date Initiated: January 22, 2024

Date Posted: March 13, 2024

Recall Number: Z-1222-2024

Event ID: 93892

Reason for Recall:

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Status: Ongoing

Product Quantity: 1,720 units (834 US, 886 OUS)

Code Information:

Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated