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Open, Classified

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

FDA Recall Z-0054-2021 · Posted None

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodeOCC
Date Initiated2018-12-10
Product Quantity1 system

Reason for Recall

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

Firm Action

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.

Root Cause

Component design/selection

Distribution Pattern

US distribution in MO. No OUS

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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