Medical Devices

Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death 

Recalled Product

  • Laboratory examination kits supplied with Simplexa™ Herpes Simplex Virus 1 & 2, and Simplexa™ Group A Strep Direct Amplification Discs

  • Model Numbers: MOL2150, MOL1451, MOL1452, MOL2850, and MOL1455  

  • Lot Numbers: 2140887, 2140332, 2127423, 2159531, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 29230, 29232, 29233, 29453, 29670, 29691, 29671, 29845, 29847, 29848, 29690, 29669, 29692, 29846, 151682, 151685, 151686, 151871, 151918, 151996, 151997, 152055, 152107, 152108, 152359, 151917, 151915, 151995, 151998, 152057, 152056

  • Manufacturing Dates: July 30, 2015 to February 11, 2016

  • Distribution Dates: September 16, 2015 to February 11, 2016

  • Devices Recalled in the U.S.: 1,658 in Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, West Virginia, Wisconsin

Device Use

The Direct Amplification Discs are Simplexa™ kit components used in combination with a molecular testing system (thermal cycler or thermocycler) to detect the presence of herpes simplex virus (HSV) or Group A Streptococcus (GAS).

Simplexa Direct Amplification Disc

Simplexa Direct Amplification Disc

Reason for Recall

Focus Diagnostics is recalling Simplexa™ Herpes Simplex Virus 1 & 2 Direct and Simplexa™ Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This poor lamination may lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results. Inaccurate diagnostic test results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death. 

Who May be Affected

  • Health care professionals using these kits to diagnose HSV 1 & 2 or GAS infections
  • All patient groups receiving a HSV 1 & 2 or GAS infection diagnosis using these kits

What to Do

On February 10, 2016, Focus Diagnostics sent a Customer Correction Notice letter to customers letting them know extra discs would be provided free of charge until the issue was resolved. The letter also asked customers to:

  • check their inventories for defective products
  • only run full discs
  • avoid running partially used discs
  • discard discs even after a partial run
  • acknowledge receipt of the letter by returning the enclosed form or by contacting Focus Diagnostics by email at Technicalinfo@focusdx.com or by fax at 562-240-6526
  • report adverse events or quality problems experienced with use of the product may also to the FDA

Date Recalled Initiated:

February 10, 2016

Page Last Updated: 04/13/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English