Class 1 Recall: Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results
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.
Thu Apr 14 2016
Class 1 Recall: 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).
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
- MedWatch Online
- Phone: 800-FDA-1088
Date Recalled Initiated:
February 10, 2016