VERIGENE Processor SP recallZ-0054-2021 · Luminex Corporation · initiated Dec 10, 2018
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
No results/incorrect results due to failure of the hybridization heater.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0054-2021
- Status
- Open, Classified
- Initiated by the company
- Dec 10, 2018
- Recalling firm
- Luminex Corporation
- Quantity
- 1 system
- Product code
- OCC
- FDA submissions
- K143653
- Distribution
- US distribution in MO. No OUS
Product description
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Code information (models, lots, serial numbers)
Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Verigene® Processor SP 10-0000-07Nanosphere, Inc. · Real Time Nucleic Acid Amplification System3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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