Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Check against the official notice below — it lists the full affected range.
Luminex Corporation is recalling the Verigene CDF Stool Prep Kit and Verigene EP Stool Prep Kit (Part No. 30-002-22) due to the potential for false negative results. The problem stems from hydrophobic characteristics of the swab used in these kits. A total of 296 units have been distributed worldwide, including throughout the United States and in Kuwait, Austria, France, Greece, and Turkey.
The affected kits are identified by specific lot numbers and UDI codes. According to the recall record, no remedy is specified for consumers who may have these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey. Quantity: 296 units 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.