Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 6,606 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 hospitalizations. The hazard is a functional defect (slide dispense issues) rather than a direct safety hazard like contamination or structural failure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides, specifically the PHBR Slides packaged as 90 slides per pack (catalog number 8221384), due to slide dispense issues. These slides are used to quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using various VITROS Chemistry Systems.
The recall involves 6,606 units, with 5,071 units distributed domestically in the United States and 1,535 units distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was nationwide in the US, including Puerto Rico, and internationally to countries including Australia, Brazil, Canada, and others.
Healthcare facilities and users of these products should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions on the recall.
The recalled product
- Product
- VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
- 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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