Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1227-2024)

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 XT 3400 Chemistry System, Catalog No. 6844458

Product Classification:

Class II

Date Initiated: January 26, 2024

Date Posted: March 13, 2024

Recall Number: Z-1227-2024

Event ID: 93925

Reason for Recall:

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

Status: Ongoing

Product Quantity: 7 US; 4 OUS

Code Information:

VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated