Z-1334-2022 Class II Ongoing
FDA device recall Z-1334-2022 was initiated by Luminex Corporation on June 17, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 296 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2022
- Initiation Date
- June 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 296 units
Product Description
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
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.