Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues. The recall affects 19,438 units distributed worldwide.
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. The source text does not report any illnesses, injuries, or deaths, and the hazard is a mechanical 'slide dispense issue' rather than a high-risk pathogen or structural defect causing immediate harm. This aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor issues without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges used with some VITROS Chemistry Product Slides. The recall is being conducted due to slide dispense issues. The affected product is the VITROS Chemistry Products PROT Slides, packaged as 90 slides per pack with catalog number 8208431. These slides are used to quantitatively measure protein concentration in cerebrospinal fluid on various VITROS Chemistry Systems.
The recall involves 19,438 units, with 8,845 units distributed domestically and 10,593 units distributed internationally. The distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous international locations such as Australia, Brazil, Canada, and several European and Asian countries. Multiple lots are affected, with expiry dates through March 22, 2015.
Healthcare facilities and users of VITROS Chemistry Systems should stop using the affected Slide Dispense cartridges. Ortho-Clinical Diagnostics is the recalling firm. Users should contact the manufacturer for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- 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 (2)
- Multiple lots affected
- with expiry dates through 22-Mar-2015
Distribution
Part of a larger recall action
This product is one of 37 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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