Home / Recalls / Focus Diagnostics Inc / Z-0238-2016

Z-0238-2016 Class II Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

Recall Details

Product Type
Devices
Report Date
November 18, 2015
Initiation Date
October 2, 2015
Termination Date
January 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38 kits

Product Description

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

Reason for Recall

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Distribution Pattern

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

Code Information

26341, 27011

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-1454-2015 Class II — STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to J (March 15, 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)