Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1677-2014·Announced 2014-06-11

Ortho-Clinical enGen Laboratory Automation System Software Recall

Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

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, and the hazard involves a delay in reporting test results rather than a direct physical injury or death, fitting the criteria for a moderate severity score.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System configured with Data Innovations, LLC Instrument Manager v8.06. The recall involves 20 units in the United States and 61 units in foreign countries, including Australia, Canada, and Germany.

The recall is due to a software anomaly where samples requiring follow-up actions, such as dilution or retesting, may be routed to the sample storage drawer before the necessary actions are completed. This issue can cause a delay in reporting patient test results because the operator is not alerted that results have not been produced and further actions are required.

The affected systems are configured with enGen Select or Custom v3.2.2 and below, Data Innovations, LLC Instrument Manager v8.06, and Data Innovations, LLC TCA Driver v8.04.0020 and below. Users should contact Ortho-Clinical Diagnostics for further instructions on resolving the software issue.

The recalled product

Product: enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Automation System
Hazard: software-anomaly
delayed-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

LLC Instrument Manager (TM) v8.06 with Data Innovations
LLC TCA Driver v8.04.0020 and below

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Ortho-Clinical Diagnostics

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