FDA Device recall Z-1092-2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system by Luminex, citing heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1092-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-05 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | AZ, CA, CO, FL, GA, IL, IN, KY, ME, MI, NE, OH, PA, TX, VT, WA |
Product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Reason
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Identifiers
| code_info | Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 2102990…Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006 |
|---|
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-1092-2022%22
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