FDA Device recall Z-2009-2021
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 by Luminex, citing potential for a false-negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2009-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-10-30 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Reason
Potential for a false-negative result.
Identifiers
| code_info | 030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B,…030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A |
|---|
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-2009-2021%22
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