—#156825

Product

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 product code: DIP — Enzyme Immunoassay, Diphenylhydantoin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K081543, K941142
Affected lot / code info: Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

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.

Timeline

Recall initiated: 2017-06-12
Terminated: 2020-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156825. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.