Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.
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 potential for biased diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides (REF/CATALOG 829 8671). These in vitro diagnostic (IVD) products are used to quantitatively measure phenytoin (PHYT) concentration in serum and plasma using specific VITROS Chemistry Systems.
The recall was initiated because the firm identified a potential for biased results to be generated when processing the product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart list serum, heparin plasma, and citrate plasma as acceptable specimen types for the assay.
The recall affects 4,680 units distributed in the US (including Puerto Rico) and 1,286 units distributed in foreign countries. The issue affects expired, current, and future product generations. Healthcare facilities and laboratories should stop using the affected slides and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS…
- Manufacturer
- Ortho-Clinical Diagnostics
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)
- Unique Identifier Number ( UDI) 10758750004690
- This issue affects expired
- current (in date) and future product GENs.
Distribution
Distributed in 1 state:
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