Recall Z-1454-2015— Focus Diagnostics Inc

Name: FDA recall Z-1454-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-15

Class II · Terminated

Class II FDA medical device recall by Focus Diagnostics Inc, initiated 2015-03-15, terminated 2015-07-23. It names one FDA 510(k) clearance: K120986. Product: STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.. Reason: 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..

Recalling firm: Focus Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-15
Terminated: 2015-07-23
Firm location: Cypress, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120986 — STRATIFY JCV DXSELECTFocus Diagnostics, Inc.·cleared 2012-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.