| Class 2 Device Recall VITROS Chemistry Products PHYT Slides | |
Date Initiated by Firm | June 12, 2017 |
Create Date | December 22, 2017 |
Recall Status1 |
Terminated 3 on August 11, 2020 |
Recall Number | Z-0273-2018 |
Recall Event ID |
77613 |
510(K)Number | K081543 K941142 |
Product Classification |
Enzyme immunoassay, diphenylhydantoin - Product Code DIP
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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. |
Code Information |
Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs. |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 513 Technology Blvd Rochester NY 14626-3601
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For Additional Information Contact | Ms. Jennifer Paine 908-218-8776 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
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. |
Quantity in Commerce | US; 4680; Foreign: 1286 |
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, Singapore, Spain, Russia and Venezuela. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DIP 510(K)s with Product Code = DIP
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