Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is test interference rather than direct physical injury or contamination, and no illnesses or injuries are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry Products TBIL-ALKP Slides (Product Code: 6844296) for in vitro diagnostic use. The recall involves the total bilirubin (TBIL) test component of the slides, while the alkaline phosphatase (ALKP) component is not affected. The slides are used to quantitatively measure total bilirubin concentration in serum and plasma.
The recall is issued due to potential interference from etrombopag, which may affect the accuracy of the TBIL test results. This issue is part of a broader recall affecting VITROS Chemistry Products TBIL Slides, VITROS BuBc Slides, and VITROS XT TBIL-ALKP Slides.
The recall covers all current, future, and past lots with UDI 10758750031801. Distribution was worldwide, including the United States and various international locations such as Australia, Belgium, Brazil, Canada, China, and others. A total of 4,076 units were distributed in the US and 949 units outside the US. Healthcare facilities and laboratories using these slides should stop using the affected TBIL test component and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
- 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 (2)
- All Current
- Future and Past Lots UDI: 10758750031801
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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