Ortho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference
Ortho Clinical Diagnostics is recalling VITROS Chemistry TP Slides because the drug eltrombopag can interfere with total protein measurements.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a specific drug interference rather than a direct physical injury or severe pathogen exposure.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Chemistry Products TP Slides (Product Code: 8392292) and VITROS XT Chemistry Products ALB-TP Slides. The recall is due to interference from the medication eltrombopag, which can affect the accuracy of total protein concentration measurements in serum and plasma.
The affected products are used with VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. The recall covers all current, future, and past lots, with a total of 491,908 units distributed worldwide, including the United States and various international markets.
Healthcare facilities and laboratories should stop using the affected slides and contact Ortho Clinical Diagnostics for further instructions. Patients should consult their healthcare providers regarding any recent test results that may have been affected by this interference.
The recalled product
- Product
- VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
- Manufacturer
- Ortho Clinical Diagnostics Inc
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 (2)
- All Current
- Future and Past Lots UDI: 10758750004850
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho Clinical Diagnostics Inc 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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