Recall Z-1274-2016 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Focus Diagnostics Inc
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
| Date | Apr 2, 2016 (initiated Feb 10, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter dated 2/10/16 was sent to all their customers who received 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). The letter informs the customers that Focus Diagnostics is recalling MOL2150 and MOL2650 kits because it may result in a false negative result, a false positive result or Error Code(s) 500 or 505. Additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. In those |
| Quantity | 41 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack Focus Diagnostics, Inc., Mar 18, 2015 |