Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. 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 score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products TRIG Slides and Slide Dispense cartridges. The recall is being conducted due to slide dispense issues. The affected products are used to quantitatively measure triglyceride concentration in serum and plasma using VITROS Chemistry Systems.
The recall includes VITROS TRIG Slides packaged as 300 slides/pack (catalog number 1336544) and 90 slides/pack (catalog number 8329930). A total of 127,662 units are affected, with 42,487 units distributed domestically in the United States and 84,906 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 countries including Australia, Brazil, Canada, and others. Users of these products should contact Ortho-Clinical Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
- 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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