Z-2009-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- October 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,338
Product Description
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Reason for Recall
Potential for a false-negative result.
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.
Code Information
030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A