Recall Z-1335-2022— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2022-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23. Reason: 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..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-17
- Firm location
- Northbrook, IL, United States
Product description
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.