Recall Z-2775-2020— Luminex Corporation
Class II · Terminated
Class II FDA medical device recall by Luminex Corporation, initiated 2020-06-15, terminated 2023-06-30. It names one FDA 510(k) clearance: K122514. Product: Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.. Reason: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-15
- Terminated
- 2023-06-30
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Reason for recall
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Data sourced from openFDA. This site is unofficial and independent of the FDA.