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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene Processor SP

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 Class 2 Device Recall Verigene Processor SPsee related information
Date Initiated by FirmApril 05, 2022
Date PostedMay 13, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1092-2022
Recall Event ID 90023
510(K)NumberK143653 
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductVerigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
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
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information ContactLuminex Global Support Services
1877-785-2323
Manufacturer Reason
for Recall		Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 04/21/22 Luminex issued a "Urgent Medical Device Recall" Notification to affected consignees. On 6/16/22 and 7/14/22 Luminex expanded the recall to include additional serial numbers. Luminex is asking consignees to take the following actions: 1. Continue use of your VERIGENE Processor SP as service has been completed by a Luminex Field Service Engineer and the Processor SP s heaters are now within specification. 2. Perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture (BC-GP) and VERIGENE Gram-Negative Blood Culture (BC-GN) Nucleic Acid Tests from 18 months prior to the most recent service visit. Identify any results that were not consistent with other clinical signs and symptoms. Promptly inform Luminex of any previously unreported incidences of false results. 3. Distribute the notification to any individuals within your organization who need to be made aware. 4. Please reach out to Global Support Services if a copy of the service record is required. 5. Please complete the Acknowledgement & Receipt form and return within 10 business days.
Quantity in Commerce24 units
DistributionUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OOI
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