Ortho-Clinical Diagnostics Recalls VITROS Chemistry Diluent Packs Due to Inaccurate Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.
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, but the hazard is limited to potential diagnostic inaccuracy (bias) with no reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 (REF 680 1754) and VITROS Chemistry Products Specialty Diluent (Lot F3168). The recall is limited to Lot 01-3266 of the FS Diluent Pack 3, which has an expiration date of September 23, 2014. A total of 1,042 units were distributed nationwide, to Puerto Rico, and to various foreign countries, including Australia, Brazil, Canada, and France.
The recall was initiated after internal testing determined that using these specific diluent lots to dilute samples for C-Reactive Protein (CRP) testing could result in approximately 51% lower than expected results. The VITROS Instructions for Use recommend using these diluents when a CRP concentration exceeds the system's measuring range. The potential for inaccurate results was confirmed by the manufacturer.
No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and laboratories should stop using the affected lots and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
- 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 01-3266 (exp. 23-SEPTEMBER-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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