Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.
What this means for you
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 specific hazard is a delay in reporting test results, which is a functional defect rather than a direct physical injury or contamination risk, fitting the Moderate severity criteria for low-risk operational issues without reported injuries.
Plain-English summary
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems (enGen) with TCAutomation Software versions 2.6, 3.2, and 3.5. The recall applies to systems configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS, and/or Tosoh AIA Systems. The issue is a software anomaly that may cause a delay in the reporting of patient sample test results.
The enGen Lab Automation System is a modification to VITROS Analyzers that includes an automated track sub-system for pre-analytical and post-analytical sample and data management. It is used for the in vitro quantitative measurement of various analytes of clinical interest. The Bypass Module interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers.
A total of 108 units are affected, comprising 31 domestic units and 77 foreign units. The products were distributed worldwide, including the United States (nationwide including Puerto Rico) and countries such as Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. No specific instructions for consumers are provided in the source text, but the recall is initiated by the manufacturer to address the software anomaly.
The recalled product
- Product
- enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modifica
- Manufacturer
- Ortho-Clinical Diagnostics
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 (4)
- TCA Software versions 2.6
- 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R)
- Abbott Architect (TM)
- VITROS (R) and/or Tosoh AIA (R) Systems
Distribution
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