> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Focus Diagnostics Class 1 Recall of Test Amplification Discs
- URL: https://www.fdaweb.com/focus-diagnostics-class-1-recall-of-test-amplification-discs/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135276

> Focus Diagnostics has begun a Class 1 recall of its Direct Amplification Discs 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 they may result in a false negative result, a false positive result or error code (s) 500 or 505\. A customer notification letter was recently sent that provided recommendations to be taken for the identified kits and the risks involved for positive results, negative results, and delayed results, according to a [recall notice](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=144240&ref=fdaweb.com).