Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0801-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

Product Classification:

Class II

Date Initiated: November 20, 2020

Date Posted: January 13, 2021

Recall Number: Z-0801-2021

Event ID: 86972

Reason for Recall:

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

Status: Terminated

Product Quantity: 40 units

Code Information:

enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated