Recall Z-1334-2022
Luminex Corporation · initiated June 17, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Codes / 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.
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 taken
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."
Details
- Recall number
- Z-1334-2022
- Initiated
- June 17, 2022
- Product code
- OZN – C. Difficile Toxin Gene Amplification Assay
- Quantity
- 296 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- Recalling firm
- Luminex Corporation, Northbrook, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1335-2022 Class II | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP… | 06/17/2022Open, Classified |