Home / Recalls / Focus Diagnostics Inc / Z-1454-2015

Z-1454-2015 Class II Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

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

Other recalls by Focus Diagnostics Inc

  • Z-1685-2017 Class II — Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitati (February 15, 2017)
  • Z-1686-2017 Class II — Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and (February 15, 2017)
  • Z-1272-2016 Class I — Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL14 (February 10, 2016)
  • Z-1274-2016 Class I — Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, (February 10, 2016)
  • Z-1273-2016 Class II — Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, (February 10, 2016)
  • Z-0238-2016 Class II — Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M (October 2, 2015)
  • Z-1958-2014 Class II — Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Si (May 15, 2014)
  • Z-1144-2014 Class II — Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the diff (February 4, 2014)
  • Z-0846-2014 Class II — Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Sim (January 10, 2014)
  • Z-0182-2013 Class III — West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, (October 3, 2012)