FDA Device recall Z-2023-2023
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 by Luminex, citing it is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2023-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-05 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Reason
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Identifiers
| code_info | UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G…UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D |
|---|
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-2023-2023%22
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