Z-1334-2022Class II

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

Name: Z-1334-2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22
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 CDF Nucleic Acid Test, Part No. 30-002-22 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-1334-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-17
Posted: 2022-07-06
Recalling firm: Luminex Corporation
Product: Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Product code: OZN C. Difficile Toxin Gene Amplification Assay
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: 296 units
Distribution: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1334-2022
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 OZN

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)