Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
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, and the source text does not report any injuries, illnesses, or deaths, indicating a moderate risk of harm.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32, which is used with the VITROS clinical chemistry analyzer. The recall is being conducted because a software anomaly in the VITROS system may result in unsuccessful calibration.
The affected product is identified by product code 6844508 and UDI 10758750032105. The recall covers worldwide distribution, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines.
Users of the VITROS system should contact Ortho Clinical Diagnostics for further instructions regarding the software anomaly and calibration issues.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- 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 (1)
- product code: 6844508 UDI: 10758750032105
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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