Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2335-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

Product Classification:

Class II

Date Initiated: July 9, 2025

Date Posted: August 27, 2025

Recall Number: Z-2335-2025

Event ID: 97210

Reason for Recall:

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Status: Ongoing

Product Quantity: 174,215 units

Code Information:

Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;

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