Z-1109-2022 Class II Ongoing
FDA device recall Z-1109-2022 was initiated by Luminex Corporation on February 15, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 984 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- February 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 984 units
Product Description
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
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.
Distribution Pattern
US
Code Information
Lot Number 101321021B