Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System
Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 57 units of the VITROS 250AT Chemistry System, Product Code 1758143. The recall covers all lots of the device, which is used to perform discrete clinical tests on serum, urine, and cerebral spinal fluid specimens.
The recall was initiated because of potential negative drift in Creatine Kinase (CK) results when the system is used. The VITROS 250AT Chemistry System is distributed nationwide in the United States.
Healthcare facilities and laboratories should stop using the affected units and contact Ortho-Clinical Diagnostics for further instructions on the recall.
The recalled product
- Product
- VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) 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) tes
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 57
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.
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