Luminex Corporation: Medical Device Recall in 2023 - (Recall #: Z-2023-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

Product Classification:

Class II

Date Initiated: June 5, 2023

Date Posted: July 5, 2023

Recall Number: Z-2023-2023

Event ID: 92451

Reason for Recall:

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Status: Ongoing

Product Quantity: 3987 units

Code Information:

UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D

Distribution Pattern:

Worldwide and US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated