FDA Device recall Z-1109-2022
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 by Luminex, citing higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1109-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-15 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | n/a |
Product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Reason
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Identifiers
| code_info | Lot Number 101321021B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1109-2022%22
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