Recall Z-2024-2023
Luminex Corporation · initiated June 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Codes / lots: UDI/DI , Lot Numbers: 071222022D, 100622022D
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-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2024-2023
- Initiated
- June 5, 2023
- Posted by FDA
- June 28, 2023
- Product code
- OZN – C. Difficile Toxin Gene Amplification Assay
- Quantity
- 114 units
- Distribution
- Worldwide and US Nationwide Distribution
- Recalling firm
- Luminex Corporation, Northbrook, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2023-2023 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… | 06/05/2023Open, Classified |