Recall Z-1092-2022
Luminex Corporation · initiated April 5, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Codes / lots: 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
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: Under Investigation by firm
Action taken
On 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.
Details
- Recall number
- Z-1092-2022
- Initiated
- April 5, 2022
- Posted by FDA
- May 13, 2022
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Quantity
- 24 units
- Distribution
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Recalling firm
- Luminex Corporation, Austin, TX