Focus Diagnostics Inc: Medical Device Recall in 2015 - (Recall #: Z-1454-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

Product Classification:

Class II

Date Initiated: March 15, 2015

Date Posted: April 29, 2015

Recall Number: Z-1454-2015

Event ID: 70856

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.

Status: Terminated

Product Quantity: 300 units

Code Information:

Lot No. 27333

Distribution Pattern:

Internationally: Denmark only.

Voluntary or Mandated:

Voluntary: Firm initiated