Device product
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Z-2011-2021
Product summary
- Event
- Event 88137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 165
- Official record key
device-enforcement:Z-2011-2021
Official wording
Reason: Potential for a false-negative result.
Code information: 050620026A and 072120026B,
Distribution pattern: Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
Potential for a false-negative result.