Device product
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Z-2008-2021
Product summary
- Event
- Event 88137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,110
- Official record key
device-enforcement:Z-2008-2021
Official wording
Reason: Potential for a false-negative result.
Code information: 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A
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.