Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue
Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 deaths. The hazard is a software anomaly affecting calibration, which is a functional defect rather than a direct physical or biological hazard to patients, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling 55 units of the VITROS 5,1 FS Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly that may result in unsuccessful calibrations. The affected units are identified by product code 6801890, UDI 10758750001644, and software version 3.1 or above.
The affected products were distributed worldwide, including in the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should check their inventory for the specific product code and software version listed above. If the affected software version is installed, users should contact Ortho Clinical Diagnostics for instructions on how to resolve the issue or replace the unit.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 55
Distribution
Part of a larger recall action
This product is one of 12 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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Similar recalls
- ModerateOrtho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect
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