Recall Z-2023-2023

Luminex Corporation · initiated June 5, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: 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

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.

FDA-determined cause: Other

Action taken

Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.

Details

Recall number
Z-2023-2023
Initiated
June 5, 2023
Posted by FDA
June 28, 2023
Product code
PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Quantity
3987 units
Distribution
Worldwide and US Nationwide Distribution
Recalling firm
Luminex Corporation, Northbrook, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2024-2023 Class IIVERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… 06/05/2023Open, Classified