Z-1092-2022 Class II Ongoing
FDA device recall Z-1092-2022 was initiated by Luminex Corporation on April 5, 2022 and is designated Class II. Reason for recall: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- April 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Reason for Recall
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Distribution Pattern
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
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