Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a diagnostic interference rather than a direct physical injury or contamination.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides, which are used for in vitro diagnostic purposes to measure bilirubin concentrations in serum and plasma. The recall is due to interference from the drug etrombopag, which affects the accuracy of the test results.
The affected products include VITROS Chemistry Products BuBc Slides with product codes 8383051 (60 slide) and 1612365 (18 slide). The recall covers all current, future, and past lots of these products. The products were distributed worldwide, including in the United States and various international locations.
Healthcare facilities and laboratories should stop using the affected VITROS Chemistry Products BuBc Slides and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the products.
The recalled product
- Product
- VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (3)
- All Current
- Future and Past Lots UDI: 10758750004829
- 10758750009398
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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