VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Check against the official notice below — it lists the full affected range.
Luminex Corporation has recalled 5,601 units of VERIGENE Enteric Pathogens Nucleic Acid Test stool preparation kits (VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT) due to a potential for false negative results. The issue is caused by hydrophobic characteristics of the swab included in the kits. The affected products were distributed worldwide, including throughout the United States and in Kuwait, Austria, France, Greece, and Turkey, with specific lot numbers and codes identified in the recall.
The recall source does not specify a remedy or course of action for affected consumers.
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: 5601 units Lot/code info: UDI 00840487101568 Luminex Lot Number 030121023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030821023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030921023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031721023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 032221023A, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032421023E, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032521023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 033021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 041421023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050521023H, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050621023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 051221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 051221023F, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 051721023B, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 052721023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060121023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060921023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 062321023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 062921023D, FLOQSwab Lot Number: 2107946;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.