QIAcube Connect MDx, Model No. 9003070
Check against the official notice below — it lists the full affected range.
Qiagen Sciences LLC is recalling QIAcube Connect MDx Model No. 9003070 devices because of a labeling problem on the info screen during the "Load tip racks and enzymes" step of run set-up. The screen states "minimal volume to be loaded" but displays the exact volume that should be loaded instead. This discrepancy could cause users to misunderstand the instructions, potentially resulting in samples that are over diluted, under diluted, or improperly lysed.
Mishandled samples could lead to false negative or false positive test results. The recall affects 93 devices distributed domestically across 25 states and Washington D.C., and 57 devices distributed internationally. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Reason for recall: During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results. Distribution: Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide. Quantity: 93 US; 57 OUS Lot/code info: UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.