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

FDA device recall Z-1092-2022 · posted 2022-05-13 · Open, Classified

Recall details

Recalling firm

Luminex Corporation

Reason for recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OOI

Quantity affected

24 units

Distribution

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

Date initiated

2022-04-05

Date posted

2022-05-13

Location

Austin, TX

Related 510(k) clearances