Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides, packaged as 300 slides per pack (catalog number 1707801), due to slide dispense issues. These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System to quantitatively measure glucose concentration in serum, plasma, urine, and cerebrospinal fluid.
The recall involves 349,072 units, with 142,455 units distributed domestically in the United States and 205,617 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 consumers should stop using the affected VITROS Chemistry Product GLU Slides and contact Ortho-Clinical Diagnostics for further instructions on returns or replacements.
The recalled product
- Product
- VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS
- 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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