VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
This recall is currently active, issued December 10, 2018. It was issued by Luminex Corporation.
- Company
- Luminex Corporation
- Recall Initiated
- December 10, 2018
- Recall Number
- Z-0054-2021
- Quantity
- 1 system
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
No results/incorrect results due to failure of the hybridization heater.
Distribution
US distribution in MO. No OUS
Lot / Code Info
Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Root Cause
Component design/selection
Action Taken
On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal.