Recall Z-0445-2019
Luminex Corporation · initiated September 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B
Reason for recall
Potential to lead to a false negative results.
FDA-determined 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.
Details
- Recall number
- Z-0445-2019
- Initiated
- September 14, 2018
- Posted by FDA
- November 10, 2018
- Terminated
- April 28, 2021
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- 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
- Recalling firm
- Luminex Corporation, Austin, TX