Luminex Corporation: Device Recall
Recall #Z-1903-2025 · 04/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1903-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Luminex Corporation
- Status
- Completed
- Date Initiated
- 04/16/2025
- Location
- Northbrook, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Reason for Recall
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Product Description
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Distribution Pattern
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Other Recalls by Luminex Corporation
- Class II: Risk 06/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.