Skip to content
Recall Observatory FDA recall evidence

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

September 14, 2018

Class II

Product summary

Firm
Luminex Corporation
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

    reason.no_named_rule · v1.0.0

    Potential to lead to a false negative results.