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Terminated

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 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall Z-0273-2018 · Posted None

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDIP
Date Initiated2017-06-12
Date Terminated2020-08-11
Product QuantityUS; 4680; Foreign: 1286

Reason for 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.

Firm Action

Ortho-Clinical Diagnostic sent an Urgent Product Correction Letter dated June 12, 2017, sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who have a VITROS analyzer that can process PHYT Slides to inform them that negatively biased results may occur when processing citrate plasma samples using VITROS Chemistry Products PHYT Slides. Customers were instructed to immediately discontinue using citrate plasma samples to process VITROS PHYT Slides. They were also informed that it is still acceptable to use serum and heparin plasma samples to process VITROS PHYT Slides. Foreign affiliates were informed by e-mail on June 12, 2017 of the issue and instructed to notify their consignees of the issue and the appropriate actions to take. For further questions, please call (908) 218-8776.

Root Cause

Device Design

Distribution Pattern

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, Singapore, Spain, Russia and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc. · 2008-10-23K941142KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOINEastman Kodak Company · 1994-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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