Ortho VITROS VANC Reagent Recalled for Potential Biased Test Results
Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.
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. The hazard involves potential for biased test results, which is a significant quality issue but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Chemistry Products VANC Reagent. The recall affects product reference code 680 1709, unique identifier 10758750006731, and is designated as an Rx Only In Vitro Diagnostic (IVD) product. The affected lots are 31-5407 (expiration date 2017-05-23), 31-5474 (expiration date 2017-07-04), and 31-5506 (expiration date 2017-07-04).
The recall was initiated due to the potential for biased results generated using these specific lots. This issue can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date. The on-analyzer stability of the VITROS VANC Reagent is determined by the system and continuously adjusted based on the time the pack is on the analyzer and the number of tests remaining.
The recall covers 2,740 units distributed in the United States (including Puerto Rico) and 616 units distributed outside the United States. International distribution included Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain, Singapore, and Venezuela. Healthcare facilities and laboratories should stop using the affected lots and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics…
- 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 (3)
- Lot numbers: 31-5407 (exp. date 2017-05-23)
- 31-5474 (exp. date 2017-07-04)
- 31-5506 (exp. date 2017-07-04)
Distribution
Distributed in 1 state:
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