Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1225-2024)

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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Product Classification:

Class II

Date Initiated: January 26, 2024

Date Posted: March 13, 2024

Recall Number: Z-1225-2024

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: 4 US; 18 OUS

Code Information:

VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J46001645

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