Class 2 Device Recall Verigene CDF Nucleic Acid Test

• Date Initiated by Firm: June 17, 2022
• Create Date: July 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1334-2022
• Recall Event ID: 90122
• Product Classification: C. Difficile toxin gene amplification assay - Product Code OZN
• Product: Verigene CDF Nucleic Acid Test, Part No. 30-002-22
• Code Information: 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.
• FEI Number: 3006028115
• Recalling Firm/ Manufacturer: Luminex Corporation; 4088 Commercial Ave; Northbrook IL 60062-1829
• For Additional Information Contact: 847-400-9000 Ext. 9029
• Manufacturer 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.
• FDA Determined 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 support@luminexcorp.com 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 support@luminexcorp.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.