Recall Z-2011-2021— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2020-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026. Reason: Potential for a false-negative result..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-10-30
- Firm location
- Northbrook, IL, United States
Product description
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Reason for recall
Potential for a false-negative result.
Data sourced from openFDA. This site is unofficial and independent of the FDA.