FDA Device recall Z-2010-2021
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 by Luminex, citing potential for a false-negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2010-2021 |
| 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 Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Reason
Potential for a false-negative result.
Identifiers
| code_info | 041520022A, 061920022A, and 081120022A |
|---|
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-2010-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.