Device product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Z-1092-2022
Product summary
- Event
- Event 90023
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1092-2022
Official wording
Reason: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Code information: 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
Distribution pattern: US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Derived failure modes
-
Unknown
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.