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Recall Observatory FDA recall evidence

Device product

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

Z-2008-2021

October 30, 2020

Class II

Product summary

Firm
Luminex Corporation
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

    reason.no_named_rule · v1.0.0

    Potential for a false-negative result.