Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1741-2014·Announced 2014-06-18

Ortho-Clinical enGen Laboratory Automation System Software Recall

Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a software anomaly (buffer timeout) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall involving a potential defect in a medical device.

Plain-English summary

Ortho-Clinical Diagnostics is recalling enGen (TM) Laboratory Automation Systems configured with TCAutomation (TM) Software version 3.5. The recall is due to a software anomaly that may cause potential buffer timeout issues. The enGen system is intended for the in vitro quantitative measurement of various analytes of clinical interest and is used in laboratory settings to manage sample workflow and data.

The recall affects 6 units distributed domestically in the United States, specifically in Arizona, Delaware, Ohio, Tennessee, and North Carolina. Additionally, 3 units were distributed internationally in Mexico, England, and Italy. The product is a modification to VITROS Analyzers that includes an automated track sub-system for pre-analytical and post-analytical sample and data management.

Healthcare facilities and laboratories using this specific configuration of the enGen Laboratory Automation System should contact Ortho-Clinical Diagnostics for further instructions on how to address the software anomaly. No specific consumer action is required for the general public, as this is a professional medical device used in clinical laboratory environments.

The recalled product

Product: enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Automation
Hazard: software-anomaly
buffer-timeout

Distribution

Distributed in 5 states:

Same manufacturer · Ortho-Clinical Diagnostics

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