Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift
Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.
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 involves a medical device with a potential for inaccurate test results (negative drift in CK), which poses a risk of harm to patients through misdiagnosis or treatment errors, but no injuries or illnesses have been reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 3,889 units of the VITROS 350 Chemistry System (Product Code 6802153, UDI # 10758750002054). The recall covers all lots and involves units distributed nationwide in the United States. The system is used to perform discrete clinical tests on serum, urine, and cerebral spinal fluid specimens using multi-layered VITROS Slides.
The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used. This issue may also affect the VITROS 250 System. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users of the VITROS 350 Chemistry System should contact Ortho-Clinical Diagnostics for instructions on how to address the recall. The source text does not provide specific consumer action steps beyond the general recall notification.
The recalled product
- Product
- VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) test
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 3,889
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →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 · inaccurate test results
See all →- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
- HighAccess Testosterone assay Catalog Number 33560 recalled
FDA (Devices) · 2025-06-11
- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- ModerateBeckman Coulter Sample Probe Manufacturing Defect Recall
FDA (Devices) · 2025-06-11
- LowApo B Reagent calibration error may produce inaccurate test results
FDA (Devices) · 2025-06-04