FDA Device recall Z-2007-2021
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 by Luminex, citing potential for a false-negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2007-2021 |
| 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 Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Reason
Potential for a false-negative result.
Identifiers
| code_info | 030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A,…030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A |
|---|
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-2007-2021%22
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