Recall Z-0445-2019 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Luminex Corporation
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.
| Date | Nov 10, 2018 (initiated Sep 14, 2018) |
| Status | Terminated |
| Reason | Potential to lead to a false negative results. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 12,700 trays |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST Nanosphere, Inc., Sep 19, 2012 |