Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1224-2024)

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 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

Product Classification:

Class II

Date Initiated: January 26, 2024

Date Posted: March 13, 2024

Recall Number: Z-1224-2024

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: 1 US; 36 OUS

Code Information:

VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers US: J36001167 OUS: J36000427 J36001117 J36001558 J36000580 J36001154 J36001570 J36000626 J36001229 J36001573 J36000688 J36001427 J36001575 J36000877 J36001451 J36001579 J36000920 J36001488 J36001582 J36000929 J36001489 J36001583 J36000942 J36001495 J36001595 J36001012 J36001519 J36001602 J36001051 J36001528 J36001608 J36001108 J36001530 J36001632 J36001111 J36001535 J36001640

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