Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
FDA device recall Z-2023-2023 · posted 2023-06-28 · Open, Classified
Recall details
- Recalling firm
- Luminex Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- PCH
- Quantity affected
- 3987 units
- Distribution
- Worldwide and US Nationwide Distribution
- Date initiated
- 2023-06-05
- Date posted
- 2023-06-28
- Location
- Northbrook, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (K140083) | Nanosphere, Inc. | 2014-06-20 |