Z-2023-2023Class II

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

Name: Z-2023-2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Creator: Luminex Corporation
Published: 2023-06-05
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2023-06-05 / Open, Classified

FDA source

Luminex Corporation began a recall of Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 on 2023-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2023-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-05
Posted: 2023-06-28
Recalling firm: Luminex Corporation
Product: Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
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 root cause: Other
Action: 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.
Quantity in commerce: 3987 units
Distribution: Worldwide and US Nationwide Distribution
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2023-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2023-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28
Z-2024-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28

Product code PCH

K140083Class IIVerigene Enteric Pathogen Nucleic Acid Test ( Ep)Nanosphere, Inc. / cleared 2014-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)