Medical device manufacturer, Abbott Laboratory, has issued a medical device safety alert concerning its ARCHITECT ICT Module. The affected devices are identified as follow:
The manufacturer has received customer complaints regarding higher than expected serum or plasma Chloride results when using the affected products. Based on an analysis of Quality Control (QC) data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected. The customer QC data do not indicate an issue with urine Chloride results.
According to the manufacturer, the issue only impacts the Chloride electrode element of the ICT module, Potassium and Sodium results are not impacted. There is the potential to generate falsely elevated serum or plasma Chloride results when using the affected products. There is also the potential to delay the reporting of Chloride ICT results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum Chloride QC results.
The affected users are advised to immediately discontinue the use of the affected products. They should destroy any remaining inventory of the impacted lot number according to their laboratory procedures. They also should discuss with their Medical Director and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
Product replacement is on-going.
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 4 September 2018