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.
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: 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…
- 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.
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
FDA (Devices) · 2018-01-03
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges
FDA (Devices) · 2013-11-27
- HighOrtho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues
FDA (Devices) · 2013-05-01
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
FDA (Devices) · 2013-11-27
- SevereOrtho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
FDA (Devices) · 2014-12-31
- ModerateOrtho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias
FDA (Devices) · 2016-12-28