VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Company
- Luminex Corporation
- Recall Initiated
- December 10, 2018
- Recall Number
- Z-0054-2021
- Quantity
- 1 system
- Firm Location
- Austin, TX
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.
More recalls by Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Oct 26, 2022
ARIES SARS-CoV-2 Assay
Jul 14, 2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
May 13, 2022
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Nov 17, 2021
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Apr 16, 2021