Ortho-Clinical enGen Laboratory Automation System Software Recall
Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software display error regarding interpretive text terminology, not a direct safety hazard or misdiagnosis of a critical condition.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 30 units of the enGen Laboratory Automation System, Product Code engen, in the United States. The recall affects software versions enGen Select 3.2 and above and enGen Custom 2.0 and above. The systems were distributed nationwide.
The recall is due to a software defect in the enGEN .gsb file. When a user selects the Comment or Interpretation option and numerical results fall between Negative and Reactive, the system incorrectly displays the interpretive text as "Borderline" and sends this incorrect text to the Laboratory Information System (LIS). The Instructions for Use (IFU) state that the correct interpretation term for these numerical result values is "Retest?". This terminology difference applies to US Markets only.
No specific instructions for consumers are provided in the source text, as this is a medical device recall affecting laboratory equipment. Affected units are identified by specific serial numbers/J numbers listed in the recall notice.
The recalled product
- Product
- enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 30
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 (20)
- Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above
- Serial Numbers/J Numbers: JIM341866
- JIM341820
- JIM341679
- JIM341352
- JIM343421
- JIM341174
- JIM336745
- JIM340667
- JIM338283
- JIM-341592
- JIM336957
- JIM341996
- JIM342334
- JIM343694
- JIM336855
- JIM334236
- JIM341415
- JIM341392
- JIM336481
Distribution
Distributed nationwide across the United States.
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