Recall Z-1109-2022
Luminex Corporation · initiated February 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Codes / lots: Lot Number 101321021B
Reason for recall
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
FDA-determined cause: Under Investigation by firm
Action taken
Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory.
Details
- Recall number
- Z-1109-2022
- Initiated
- February 15, 2022
- Product code
- PEP – Molecular Erythrocyte Typing Test
- Quantity
- 984 units
- Distribution
- US
- Recalling firm
- Luminex Corporation, Northbrook, IL