Z-1335-2022Class II

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

Name: Z-1335-2022 VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Creator: Luminex Corporation
Published: 2022-06-17
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2022-06-17 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 on 2022-06-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1335-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-17
Posted: 2022-07-06
Recalling firm: Luminex Corporation
Product: VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified its consignees of the recall by letter on 06/17/2022. The letter explained the issue and provided the following actions be taken: "Customer Action: 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected VERIGENE Stool Sample Preparation Kits in your possession (reference Tables 1 & 2 for impacted kit lots), please contact Luminex Global Support Services at [email protected] to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Enteric Pathogens Nucleic Acid test and VERIGENE CDF Nucleic Acid test from 3/25/2021 to11/29/2021. If you have encountered a false negative result with a patient sample tested with kits received during this time frame, please contact Luminex Global Support Services at [email protected] 4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. 5. Please complete the Acknowledgement & Receipt Form and return it to Luminex Technical Support. 6. For those with complaints, questions, or concerns, please contact Luminex Global Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381-4397 (Outside U.S. and Canada). 7. Reports can also be made directly to the FDA MedWatch Serious Injury Reporting Program online by completing and submitting the report online at: www.fda.gov/medwatch/report, or by regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178."
Quantity in commerce: 5601 units
Distribution: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
Product codes and lots: 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; Luminex Lot Number 063021023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 063021023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070121023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070621023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023G, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023H, FLOQSwab Lot Number: 2107946; Luminex Lot Number 080321023C, FLOQSwab Lot Number: 2107946; Luminex Lot Number 081621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081721023F, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 081721023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081921023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082021023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 082021023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082521023D, FLOQSwab Lot Number: 2100856, 2110850; Luminex Lot Number 082621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 083121023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 090821023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091521023D, FLOQSwab Lot Number: 2032870; Luminex Lot Number 091621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091621023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092721023A, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092821023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092921023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 100621023C, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101321023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101921023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102021023E, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 102221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102821023F, FLOQSwab Lot Number: 2107946.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1335-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1334-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-06
Z-1335-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-06

Product code PCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)