Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or performance issues without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides, Product Code 684 4471. These in vitro diagnostic slides are used to measure chloride concentration in serum, plasma, and urine on VITROS Chemistry Systems. The recall involves 168,919 units distributed worldwide, including the United States and 25 foreign countries.
The slides are being recalled because they failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantification (LoQ) for urine samples. Specifically, the Limit of Quantification (LoQ) determined by the investigation is 15 mmol/L, whereas the current claimed LoQ is 5 mmol/L. The measuring range of 15-300 mmol/L for urine samples is not affected.
This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences. The slides are used for the diagnosis and treatment of electrolyte and metabolic disorders. Users should stop using the affected slides and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VI
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 168,919
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 (1)
- GEN 10 and above
Distribution
Distributed nationwide across the United States.
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