Ortho-Clinical Diagnostics Recalls VITROS SALI Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS SALI Slides because the associated Slide Dispense cartridges have 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. The hazard involves a mechanical dispense issue rather than a direct biological or chemical contamination, and no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products SALI Slides packaged as 90 slides per pack (catalog number 1314343). These slides are used to quantitatively measure salicylate concentration in serum and plasma on VITROS Chemistry Systems.
The recall is being conducted because the Slide Dispense cartridges used with these slides are experiencing slide dispense issues. The affected units include 15,492 total units, with 11,870 distributed domestically and 3,622 distributed internationally. The recall covers multiple lots with expiry dates through March 22, 2015.
The product was distributed nationwide in the United States, including Puerto Rico, and internationally to countries including Australia, Brazil, Canada, and others. Users of VITROS Chemistry Systems should stop using the affected Slide Dispense cartridges and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- 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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