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Open, Classified

Revogene, Catalog no. 610210. IVD test instrument

FDA Recall Z-1479-2022 · Posted None

Recalling FirmMeridian Bioscience Inc
Recall StatusOpen, Classified
Product CodeOOI
Date Initiated2022-06-22
Product Quantity459 (394 US, 65 OUS)

Reason for Recall

When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.

Firm Action

On June 22, 2022, the firm notified customers via email. Customers were instructed that if a run is aborted and an error code presented, they SHOULD NOT open the instrument. DO NOT touch the retention ring or the inside of the lid as they may be hot. The firm recommends that customers wait approximately 10 minutes to allow the instrument to cool prior to opening the lid and removing the test devices. The firm has developed a firmware solution to prevent the lid from being opened after an aborted run prior to the completion of the cooling period. The Meridian Bioscience Technical Services team will contact you to set up an appointment for firmware installation once available.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170558revogeneGenepoc, Inc. · 2017-05-25

Official Source

View FDA Recall →

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

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