Simplexa Flu a/B & Rsv Direct, Simplexa Flu a/B & Rsv Positive Control Pack

• • Terminated Z-1958-2014 FDA Class II ·initiated 15 May 2014

  Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.

• • Terminated Z-0846-2014 FDA Class II ·initiated 10 Jan 2014

  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.

510(k) Number

K120413 ↗

FDA Product Code

OCC

Device Class

Class II

Regulation

21 CFR Part 866.3980

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• HerpeSelect Express IgG, HerpeSelect Express Controls, Models RT0920G, RT0950

  Class II

  FDA 510(k) K071510 Active Cleared 24 Sep 2007

• Simplexa C. Difficile Universal Direct

  Class I

  FDA 510(k) K113433 Active Cleared 4 Apr 2012

• Plexus Herpeselect 1 and 2 Igg (with Plexus Tm Software), Model MP0900G

  Class II

  FDA 510(k) K071511 Active Cleared 5 Oct 2007

• Simplexa Flu a/B & Rsv

  Class II

  FDA 510(k) K102170 Active Cleared 24 Nov 2010

• Simplexa Hsv 1&2 Direct/Positive Control Pack

  Class II

  FDA 510(k) K141458 Active Cleared 1 Jul 2014

• Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

  Class II

  FDA 510(k) K150962 Active Cleared 28 Aug 2015

See all devices from Focus Diagnostics, Inc. →