Home / Recalls / Focus Diagnostics Inc / Z-0846-2014

Z-0846-2014 Class II Terminated

Recalled by Focus Diagnostics Inc — Cypress, CA

Recall Details

Product Type
Devices
Report Date
February 5, 2014
Initiation Date
January 10, 2014
Termination Date
October 15, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,052 kits

Product Description

Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is 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.

Reason for Recall

Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.

Distribution Pattern

Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .

Code Information

Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.

Other recalls by Focus Diagnostics Inc

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  • Z-1685-2017 Class II — Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitati (February 15, 2017)
  • 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-1272-2016 Class I — Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL14 (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-1144-2014 Class II — Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the diff (February 4, 2014)
  • Z-0182-2013 Class III — West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, (October 3, 2012)