Ortho-Clinical Diagnostics Recalls VITROS Specialty Diluent Due to Inaccurate CRP Results
Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.
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 hazard involves inaccurate test results without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Specialty Diluent (Lot F3168) and VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The recall is due to the potential for lower than expected C-Reactive Protein (CRP) results when these diluents are used.
Internal testing determined that using a 3x dilution factor with VITROS CRP Slides and the affected diluents has the potential for approximately 51% bias in the results. The VITROS Instructions for Use recommend using these diluents when a C-reactive protein concentration exceeds the system's measuring range.
A total of 1,656 units were distributed nationwide, to Puerto Rico, and to foreign countries including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
- 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 (1)
- Lot F3168 (exp. 30 Sep 2014)
Distribution
Part of a larger recall action
This product is one of 2 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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