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Recall Observatory FDA recall evidence

Device product

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Z-1092-2022

April 05, 2022

Class II

Product summary

Firm
Luminex Corporation
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

    reason.no_named_rule · v1.0.0

    Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.