VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2015.
Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2015.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
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- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0007-2015.
Ortho-Clinical Diagnostics
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Ortho-clinical Diagnostics Recall FAQ
Ortho-clinical Diagnostics is the subject of a diagnostic devices safety report: VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry .... The notice was published on August 20, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 339 units are potentially affected.