Qiagen Sciences LLC QIAcube Connect MDx, Model No. 9003070 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QIAcube Connect MDx, Model No. 9003070
Brand
Qiagen Sciences LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Qiagen Sciences LLC is recalling QIAcube Connect MDx, Model No. 9003070 due to 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 i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customers were notified of the initial issue by email beginning Nov 3 2021, and requested to return acknowledgment of the notice. On January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, DE, FL, GA, IA, KS, LA, MD, MA, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI, DC
Page updated: Jan 10, 2026