Medical device manufacturer, Abbott, has issued a medical device safety alert concerning ARCHITECT Ceruloplasmin assay and Alinity c Ceruloplasmin Reagent Kit. The affected devices are identified as follow:
Abbott has received a Field Safety Notice (FSN) from Sentinel Diagnostic, which is the manufacturer of ARCHITECT Ceruloplasmin assay and Alinity c Ceruloplasmin Reagent Kit, confirmed that the EDTA specimen collection tube type did not meet the samples storage stability claim listed in the package insert and is no longer acceptable for use.
According to the manufacturer, package insert of the Ceruloplasmin assay lists the EDTA as suitable anticoagulant for sampling collection tube. However, the EDTA sample tube storage claims are not met with the new studies performed. In particular, the stability claims of 2 weeks at 2 – 8 oC and 8 days at room temperature are not confirmed, both for Dipotassium and for Tripotassium EDTA. There is a potential for incorrect patient results when the EDTA specimen type is used.
Based upon recent specimen storage testing, the specimen storage information is being revised with an update to the SPECIMEN COLLECTION AND HANDLING section of the Instructions for Use (IFU) for the ARCHITECT Ceruloplasmin assay and to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the IFU for the Alinity c Ceruloplasmin assay.
Affected users are advised to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 June 2019