Simplexa Hsv 1&2 Direct/Positive Control Pack

• • Terminated Z-2547-2020 FDA Class II ·initiated 12 May 2020 ·on shared 510(k) K141458

  Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

• • Terminated Z-1272-2016 FDA Class I ·initiated 10 Feb 2016

  Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K141458 ↗

FDA Product Code

PGH

Device Class

Class II

Regulation

21 CFR Part 866.3307

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, Simplexa HSV 1 & 2 Positive Control Pack

  Class II

  FDA 510(k) K150962 Active Cleared 28 Aug 2015

• 3M Integrated Cycler (110V) & (220V)

  Class II

  FDA 510(k) K102314 Active Cleared 29 Oct 2010

See all devices from Focus Diagnostics, Inc. →