FDA Device recall Z-2008-2021
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 by Luminex, citing potential for a false-negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2008-2021 |
| 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 Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Reason
Potential for a false-negative result.
Identifiers
| code_info | 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A,…030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A |
|---|
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-2008-2021%22
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