Home / Recalls / Focus Diagnostics Inc / Z-1144-2014

Z-1144-2014 Class II Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
February 4, 2014
Termination Date
November 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,175 kits

Product Description

Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

Reason for Recall

Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

Distribution Pattern

Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

Code Information

Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

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-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-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)