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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1092-2022 |
| Event ID | 90023 |
| Event Description | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system |
| Product Type | Devices |
| Distribution | US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None |
| Quantity | 24 units |
| Recall Reason | Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. |
| Device Classification | 20220525 |
| Device Code Info | 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 |
| Center Classification Date | 20220513 |
| Recall Initiation Date | 20220405 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | |
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