Ortho-Clinical Diagnostics Recalls VITROS Chemistry Fe Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Fe Slides due to slide dispense issues. The recall affects 37,525 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. The hazard is a mechanical dispense issue rather than a direct biological or chemical contamination, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Fe Slides, which are used to quantitatively measure iron concentration in serum and plasma. The recall is 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 1515808) and 90 slides per pack (catalog number 1924547). A total of 37,525 units are affected, with 11,898 units distributed domestically in the United States and 25,627 units distributed internationally. The recall covers multiple lots with expiry dates through March 22, 2015.
Distribution was worldwide, including all 50 U.S. states, the District of Columbia, Puerto Rico, and various international locations such as Australia, Brazil, Canada, and several European and Asian countries. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
- 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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