Ortho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.
What this means for you
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: This is a voluntary precautionary recall for a potential quality issue (biased results) in a medical device where no specific injuries or illnesses have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT (Phenytoin) Slides, Lot 2613-0150-4913. The recall was initiated because the company identified a potential for biased results to be generated when using these specific slides.
The issue was discovered during testing of a different lot of VITROS PHYT Slides, where some positively biased results were identified. Although the affected slides from that other lot were not released for distribution, the recalled Lot 2613-0150-4913 was manufactured in the same event, creating the potential for it to be similarly affected.
The recalled slides were distributed nationwide in the United States and in Singapore. A total of 339 domestic sales units and 10 foreign sales units were distributed. Users should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
- 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 (2)
- Lot Number 2613-0150-4913
- exp. 15-Nov-2014
Distribution
Distributed nationwide across the United States.
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