Medical device manufacturer and distributor, Roche Diagnostics, has issued a medical device safety alert concerning its cobas p 501 / 701 post-analytical units [Part Number: 05158494001, 05349966001].
The Tray Input Flap on the cobas p 501 and cobas p 701 post-analytical units has the potential to become unsecured from the instrument. The Tray Input Flap screws can become loose on the cobas p 501 or p 701 post-analytical units resulting in the potential detachment from the instrument.
According to the manufacturer, visual inspection of the Tray Input Flap, plate and screws were performed. The flap was no longer attached to the instrument and the 4 M3 threads on the Tray Input Flap were worn out resulting in the screws not working as intended.
This design of Tray Input Flap was installed on all instruments with the following Serial Numbers:
Instruments with Serial Numbers higher than 1044 for the cobas p 501 and higher than 1037 for the cobas p 701 are not affected as they have a newer design of Tray Input Flaps.
The Tray Input Flaps on instruments with the above listed serial numbers must be replaced by the manufacturer with the current design of the tray input flaps.
Prior to the replacement tray input flaps being installed, the affected users must be informed that they should always inspect their tray input flap to ensure the tray input flap is securely attached to the instrument. If the flap is not fastened securely or becomes loose prior to the tray input flap being replaced, they must contact the manufacturer to repair the instrument.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 March 2019