Z-1454-2015 Class II Terminated
FDA device recall Z-1454-2015 was initiated by Focus Diagnostics Inc on March 15, 2015 and is designated Class II. 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 po… The recall status is terminated (terminated July 23, 2015). Affected quantity: 300 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- March 15, 2015
- Termination Date
- July 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 units
Product Description
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
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.
Distribution Pattern
Internationally: Denmark only.
Code Information
Lot No. 27333