FDA Device recall Z-0920-2022
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R by Luminex, citing two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0920-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-04-22 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | CT, LA, TX |
Product
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Reason
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Identifiers
| code_info | Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010 |
|---|
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-0920-2022%22
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