medical Class II Updated 2022-07-13

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
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