Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results

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

AUDIENCE: Risk Manager, Internal Medicine, Patient

ISSUE: 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.

Model Numbers: MOL2150, MOL1451, MOL1452, MOL2850, and MOL1455.
Manufacturing Dates: July 30, 2015 to February 11, 2016
Distribution Dates: September 16, 2015 to February 11, 2016

BACKGROUND: 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).

RECOMMENDATION: 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

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm496099.htm