Siemens healthcare diagnostics is conducting a correction for the immulite 2000 and immulite 2000 xpi immunoassay systems water and liquid waste bottles received starting may 2013.Siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue.The smaller diameter opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.Urgent medical device correction (umdc) 2015-03-05 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers in the united states and urgent field safety notice (ufsn) 3022 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers outside the united states in march 2015.The umdc/ufsn describes how to identify a defective bottle and actions to take if a defective bottle is identified.
|