Ortho-Clinical VITROS Lithium Slides Recalled for Imprecision
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Lithium Slides due to intermittent imprecision in 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, but the source text explicitly states the issue is intermittent imprecision without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Chemistry Products Li (Lithium) Slides. The affected products are REF/Catalog Number 1632660 (Lot 3124-0108-6568) and REF/Catalog Number 8318925 (Lot 3124-0108-6569). These are prescription-only in vitro diagnostic (IVD) devices used for measuring lithium levels.
The recall was initiated because of intermittent imprecision in the results generated using these two specific lots. The source text does not report any illnesses, injuries, or deaths associated with the use of these slides.
The affected units were distributed in the US, Puerto Rico, Canada, the EU, China, Brazil, Chile, and the Dominican Republic. Healthcare facilities and laboratories should stop using the affected lots and contact Ortho-Clinical Diagnostics for instructions on returning or disposing of the product.
The recalled product
- Product
- VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720,
- 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 (4)
- REF/Product Code 1632660: Lot 3124-0108-6568
- exp. 2018- 04-01
- REF/Product Code 8318925: Lot 3124-0108-6569
- exp. 2018- 05-01
Distribution
Distributed in 1 state:
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