Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-1334-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 17, 2022

Date Posted: July 13, 2022

Recall Number: Z-1334-2022

Event ID: 90122

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.

Status: Ongoing

Product Quantity: 296 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated