medical Class II Updated 2021-01-13

Ortho-Clinical Diagnostics, Inc. recalls VITROS Automation Solutions, VAS, Catalog Numbers 6844300 &

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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