Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its PK7400 Automated Microplate System [Software Versions 1.04 and 1.05].
The manufacturer is informing users of a software malfunction in its PK7400 Automated Microplate System with the above software versions. Due to this software malfunction, if affected users operate with more than one new data index per day*, they may not be able to create a new index when the number of indexes in the system reaches the maximum limit of 300. If this occurs, an error dialog "Cannot create an index" will open when users try to create an index in the Start Conditions screen, and they will not be able to create a new index. This phenomenon will also occur if affected users have created multiple indexes in the same day* and transmitted the data included in those indexes to the laboratory information system (LIS) even once in the past.
According to the manufacturer, when affected users cannot create a new index, they cannot start the analysis by a new index. This could lead to a delay in testing. This issue will be fixed in the next software version.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products with the abovementioned issues, please contact your supplier for necessary action.
(* per day or in the same day is defined as the time between powering on the PK7400 and shutting it down.)
Posted on 26 April 2021