FDA Device recall Z-2006-2021
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 by Luminex, citing potential for a false-negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2006-2021 |
| 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 Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Reason
Potential for a false-negative result.
Identifiers
| code_info | 030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A,…030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A |
|---|
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-2006-2021%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.