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VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processi...

FDA Recall #Z-0054-2021 — Class II — December 10, 2018

Recall #Z-0054-2021 Date: December 10, 2018 Classification: Class II Status: Ongoing

Product Description

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Reason for Recall

No results/incorrect results due to failure of the hybridization heater.

Recalling Firm

Luminex Corporation — Austin, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 system

Distribution

US distribution in MO. No OUS

Code Information

Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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