FDA Device recall Z-0054-2021
VERIGENE Processor SP Model No. 10-0000-07
- FDA Device
- Class II
- ongoing
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of VERIGENE Processor SP Model No. 10-0000-07 by Luminex, citing no results/incorrect results due to failure of the hybridization heater.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0054-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-10 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Luminex |
| Distribution | MO |
Product
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Reason
No results/incorrect results due to failure of the hybridization heater.
Identifiers
| code_info | Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0054-2021%22
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