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U.S. Department of Health and Human Services

Class 2 Device Recall STRATIFY JCV DxSelect

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  Class 2 Device Recall STRATIFY JCV DxSelect see related information
Date Initiated by Firm March 15, 2015
Date Posted April 17, 2015
Recall Status1 Terminated 3 on July 23, 2015
Recall Number Z-1454-2015
Recall Event ID 70856
510(K)Number K120986  
Product Classification Anti-jcv antibody detection assay - Product Code OYP
Product STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Code Information Lot No. 27333
Recalling Firm/
Manufacturer		 Focus Diagnostics Inc
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact
714-220-1900
Manufacturer Reason
for Recall		 Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to DxTS@focusdx.com.
Quantity in Commerce 300 units
Distribution Internationally: Denmark only.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = OYP and Original Applicant = FOCUS DIAGNOSTICS, INC.
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