Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas 6800/8800 Systems RACK TRAY, 75 POS. COLLAPSIBLE, RDR [Cat No.: 11909797001] and 75pos. Roche/ Hitachi Racktray IM [Cat No.: 11906984001].

According to the manufacturer's internal investigation and case management system, it was reported that circlips of sample rack trays were missing. Dislodging of retaining rings or circlips were observed on the affected sample rack trays, which may cause tray breakage.

The manufacturer recommends the following actions to affected users:

• Perform visual check prior to each use in order to ensure all retaining rings or circlips on rack tray are present. They should stop using any rack tray with any retaining ring or circlip missing.
• While using the rack tray, hold the handle by one hand while another hand supports the tray base to prevent accidental drop of rack tray.
• Handle with care while using the rack trays; avoid extra force of impact when loading rack trays to Sample Supply Module (SSM) with proper alignment between rack trays and SSM.

According to the local supplier, the products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary action.

Posted on 1 April 2021