Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1675-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

Product Classification:

Class II

Date Initiated: July 19, 2022

Date Posted: September 14, 2022

Recall Number: Z-1675-2022

Event ID: 90681

Reason for Recall:

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

Status: Ongoing

Product Quantity: 506 units

Code Information:

UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated