Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 85,646 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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a functional defect (slide dispense issues) rather than a direct biological or physical safety hazard like contamination or fire, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. The affected products include VITROS Chemistry Products URIC Slides packaged as 300 slides/pack, catalog number 1943927. These slides are used to quantitatively measure uric acid concentration in serum, plasma, and urine using various VITROS Chemistry Systems.
The recall involves 85,646 units, with 13,640 units distributed domestically in the United States and 72,006 units distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was worldwide, including all 50 U.S. states, Puerto Rico, and numerous international locations such as Australia, Brazil, Canada, and several European and Asian countries.
Healthcare facilities and laboratories using these products should stop using the affected Slide Dispense cartridges and contact Ortho-Clinical Diagnostics for further instructions on the recall.
The recalled product
- Product
- VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated
- 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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