Ortho-Clinical Diagnostics VITROS PHYT Slides Recall: Citrate Plasma Risk
Ortho-Clinical Diagnostics recalls VITROS PHYT Slides (REF 829 8671) for potential biased results with citrate plasma. This affects lab tests using these slides for phenytoin measurement.
Lower-risk recall
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
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What happened, in plain English
Ortho-Clinical Diagnostics is recalling VITROS PHYT Slides (REF/CATALOG 829 8671) because they may produce inaccurate test results when used with citrate plasma samples. This could lead to incorrect phenytoin levels in blood tests, which is critical for seizure management. Read more at govinfonow.com/recall/73883-ortho-clinical-diagnostics-vitros-phyt-slides-recall-citrate-plasma-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73883-ortho-clinical-diagnostics-vitros-phyt-slides-recall-citrate-plasma-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0273-2018
Cite this page
“Ortho-Clinical Diagnostics VITROS PHYT Slides Recall: Citrate Plasma Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73883-ortho-clinical-diagnostics-vitros-phyt-slides-recall-citrate-plasma-risk. Based on FDA recall #Z-0273-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0273-2018%22&limit=1).
Why it’s dangerous
The slides are designed to measure phenytoin in serum or heparin plasma, but the instructions incorrectly list citrate plasma as acceptable. Using citrate plasma with these slides can cause biased results, potentially leading to wrong medication dosing.
Who’s affected
Lab users who perform phenytoin blood tests with these slides may be affected. Patients on seizure medication are at risk of incorrect dosing if their tests are impacted.
How to tell if you have this one
Check for VITROS PHYT Slides with reference number 829 8671. These are used for phenytoin testing in labs and are sold for in vitro diagnostic use only.
- Brand
Ortho-Clinical Diagnostics- Category
Medical device
What to do — step by step
Check Specimen Type
Verify if your lab uses citrate plasma samples with these slides. If so, stop using them immediately.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this a safety hazard?
No, this is a potential for inaccurate test results, not a physical safety risk. The hazard is low risk as it affects test accuracy, not direct injury.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0273-2018 (June 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0273-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.