Ortho-Clinical VITROS UPRO Slides Recalled for Variable Urine Protein Results
Ortho-Clinical Diagnostics is recalling VITROS UPRO Slides because they may produce variable urine protein results.
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, and the source text describes a potential for variable results without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products UPRO Slides (UPN 10758750000593) due to a potential for variable negatively and positively biased urine protein results. The affected product is used for the quantitative measurement of total protein concentration in urine.
The recall covers 37,571 packs containing 90 slides each, totaling 3,381,390 slides. The specific product code is REF 680 0120, with lot numbers GENs 14-18 and an expiry date range from 01-JAN-2017 through 01-MAY-2018.
The product was distributed worldwide, including nationwide in the U.S.A. and internationally in Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, and Poland. Users should stop using the affected slides and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
Distribution
Distributed nationwide across the United States.
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