Recall Z-1454-2015
Focus Diagnostics Inc · initiated March 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Codes / lots: Lot No. 27333
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1454-2015
- Initiated
- March 15, 2015
- Posted by FDA
- April 17, 2015
- Terminated
- July 23, 2015
- Product code
- OYP – Anti-Jcv Antibody Detection Assay
- Quantity
- 300 units
- Distribution
- Internationally: Denmark only.
- Recalling firm
- Focus Diagnostics Inc, Cypress, CA