Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly
Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.
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 source text describes a software anomaly affecting autoverification but does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics has issued an Urgent Product Correction Notification for the enGen Track System with enGen Custom v3.2.2 and earlier versions. The recall involves 20 units of the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System, which is intended for in vitro quantitative measurement of clinical analytes.
The recall is due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems. This issue may impact the reliability of the laboratory automation process.
The affected products were distributed worldwide, including in the United States (AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC) and in Chile, India, Italy, Portugal, Spain, Sweden, and the UK. Users of the affected software should contact Ortho-Clinical Diagnostics for further instructions on how to address the anomaly.
The recalled product
- Product
- enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Pr
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 20
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 (1)
- Custom v3.2.2 & Below Configuration Files
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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