Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text cites 'slide dispense issues' without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional defect rather than a critical safety hazard.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products AMON Slides, which are used to quantitatively measure ammonia concentration in plasma. The recall is being conducted due to slide dispense issues with the Slide Dispense cartridges used with these products.
The affected products are packaged as 300 slides per pack (catalog number 1721869) and 90 slides per pack (catalog number 1726926). A total of 24,322 units are involved in the recall, with 12,329 units distributed domestically in the United States and 11,993 units distributed internationally. The affected lots have expiry dates through March 22, 2015.
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 distribution across all 50 U.S. states, the District of Columbia, Puerto Rico, and various international locations including Australia, Brazil, Canada, and several European and Asian countries.
The recalled product
- Product
- VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems 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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