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Luminex Corporation Recall 90023

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

Luminex Corporation Recall 90023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1092-2022
Event ID90023
Event DescriptionVerigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Product TypeDevices
DistributionUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Quantity24 units
Recall ReasonHeater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Device Classification20220525
Device Code InfoSerial 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
Center Classification Date20220513
Recall Initiation Date20220405
Recalling FirmLuminex Corporation
Initial Notification E-Mail
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