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Recall Observatory FDA recall evidence

Device product

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

Z-1334-2022

June 17, 2022

Class II

Product summary

Firm
Luminex Corporation
Event
Event 90122
Status
Ongoing
Classification
Class II
Quantity
296 units
Official record key
device-enforcement:Z-1334-2022

Official wording

Reason: There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

Code information: UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.