Recall Z-2023-2023 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
| Date | Jun 28, 2023 (initiated Jun 5, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 3987 units |
| Distribution | Worldwide and US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) Nanosphere, Inc., Jun 20, 2014 |