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.
This recall has been terminated (originally issued November 10, 2018).
- Company
- Luminex Corporation
- Recall Initiated
- September 14, 2018
- Posted
- November 10, 2018
- Terminated
- April 28, 2021
- Recall Number
- Z-0445-2019
- Quantity
- 12,700 trays
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Potential to lead to a false negative results.
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
Lot / Code Info
Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B
Root Cause
Nonconforming Material/Component
Action Taken
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.