Device 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.
Z-0445-2019
Product summary
- Event
- Event 81220
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,700 trays
- Official record key
device-enforcement:Z-0445-2019
Official wording
Reason: Potential to lead to a false negative results.
Code information: Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B
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
Derived failure modes
-
Unknown
Potential to lead to a false negative results.