Ortho-Clinical enGen Track System Software Recall for Result Delays
Ortho-Clinical Diagnostics is recalling 16 enGen Track Systems with TCAutomation Software Version 4.2 due to a software anomaly that may delay result reporting.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (delayed results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 16 units of the enGen Track System with TCAutomation Software Version 4.2. The recall is due to a software anomaly that may cause a delay in reporting results. This occurs when patient samples are reintroduced back onto the enGEN track and are routed to an unintended location.
The affected units are distributed domestically in Georgia, Illinois, Missouri, North Carolina, and New York, as well as internationally in Canada, England, France, Italy, and Spain. The specific serial numbers involved are 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J, and JG7BFB5J, with product codes 952019-EG, 952020-EG, and 952055.
Healthcare facilities should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly and ensure proper sample routing.
The recalled product
- Product
- enGen Track System with TCAutomation Software Version 4.2
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 16
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 (7)
- Serial numbers: 5GV6W2J
- 3RHC23J
- 7KSC15J
- 953252
- CXL941J & JG7BFB5J Product Code 952019-EG
- 952020-EG
- 952055
Distribution
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · software anomaly
See all →- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo infusion pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10