Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides due to slide dispense issues.
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, indicating a risk of harm that is unlikely to cause serious adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides, which are used to quantitatively measure unconjugated and conjugated bilirubin concentrations in serum and plasma. The recall involves Slide Dispense cartridges used with these slides due to slide dispense issues.
The affected products include VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack (catalog number 8383051) and 90 slides/pack (catalog number 1612365). These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall covers 74,792 units, with 35,501 units distributed domestically in the United States and 60,291 units distributed internationally.
The affected lots have expiry dates through March 22, 2015. The products were distributed nationwide in the United States, including Puerto Rico, and internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain. Users should contact Ortho-Clinical Diagnostics for further instructions on handling the recalled products.
The recalled product
- Product
- VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma u
- 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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