Ortho-Clinical Diagnostics Recalls enGen Track System Due to Autoverification Anomaly
Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 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 describes a software anomaly affecting autoverification without reporting specific injuries or illnesses, aligning with a moderate severity rating for a precautionary correction.
Plain-English summary
Ortho-Clinical Diagnostics has issued an Urgent Product Correction Notification for the enGen Track System with enGen Select v5.0 with autoverification enabled. The recall involves 8 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 was initiated due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems. The affected software versions are enGen Select V5.0 and enGen Custom v3.2.2.
The product was distributed worldwide, including nationwide in the United States in the states of AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, and NC, as well as in Chile, India, Italy, Portugal, Spain, Sweden, and the UK. Users of the affected systems should contact Ortho-Clinical Diagnostics for further instructions regarding the product correction.
The recalled product
- Product
- enGen Track System with enGen Select v5.0 with autoverification enabled 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 V
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 8
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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