Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.
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. The hazard involves potential misdiagnosis or inappropriate medical intervention, which poses a risk of harm, but no injuries or illnesses have been reported to date.
Plain-English summary
Ortho-Clinical Diagnostics is recalling enGen (TM) Laboratory Automation Systems that use TCAutomation (TM) Software with the InOut Communication Interface. The recall involves 33 units in the United States and 43 units outside the US. The systems are distributed across multiple US states and various foreign countries.
The recall is due to a software anomaly involving communication between Thermo-Fisher Scientific Bypass modules and VITROS Analyzers. This issue may cause sample IDs to become misassociated with the actual samples being processed. If this occurs, assay results may be reported for the wrong sample ID, and subsequent samples may also have misassociated results until the system is reset. This could potentially lead to misdiagnosis or inappropriate medical intervention.
To date, no occurrences of this issue have been observed on Ortho's enGen Systems, and no patient harm has been reported. The anomaly requires a specific set of conditions to occur, including an RFID tag read failure and the VITROS System being unavailable to aspirate. Users should contact Ortho-Clinical Diagnostics for further instructions on how to address this issue.
The recalled product
- Product
- enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
- 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 (20)
- US Serial Numbers/J Numbers: B3ZHP2J/JB3ZHP2J
- 736BM4J/J736BM4J
- 953289/J953289
- 953252/J953252
- HJ5K84J/JHJ5K84J
- FCM073J/JFCM073J
- HPKG25J/JHPKG25J
- GWXQ52J/JGWXQ52J
- GBX395J/GBX395J
- JFBX395J/JFBX395J
- FXCBG3J/JFXCBG3J
- 3RHC23J/J3RHC23J
- JG7BFB5J/JG7BFB5J
- 953270/J953270
- 953221/J953221
- 54FC01J/J54FC01J
- 953209/J953209
- 5J4B45J/J5J4B45J
- 5LQ6Q2J/ J5LQ6Q2J
- 2Z3YV1J/J2Z3YV1J
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