Ortho Clinical Diagnostics Recalls VITROS 250AT Chemistry Systems Due to Software Anomaly
Ortho Clinical Diagnostics is recalling 30 VITROS 250AT Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
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 illnesses. The hazard is a software anomaly leading to unsuccessful calibration, which is a functional defect rather than a direct physical or biological hazard with reported harm.
Plain-English summary
Ortho Clinical Diagnostics is recalling 30 units of the VITROS 250AT Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly in Version 9.7 that may result in unsuccessful calibration.
The affected units were distributed worldwide, including in the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The product code is 1758143 and the UDI is 10758750000036.
Healthcare facilities should contact Ortho Clinical Diagnostics for instructions on how to address the software issue. No specific instructions for end-users are provided in the source text.
The recalled product
- Product
- VITROS 250AT Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 30
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)
- product code: 1758143 UDI: 10758750000036 Affected software : Version 9.7
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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