VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
FDA Recall Z-0445-2019 · Posted 2018-11-10
Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodePAM
Date Initiated2018-09-14
Date Terminated2021-04-28
Product Quantity12,700 trays
Reason for Recall
Potential to lead to a false negative results.
Firm Action
On September14, 2018, Luminex sent Urgent Customer Advisory Notifications to their consignees. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Experience Team.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.