Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2014-RN-00562-1

Class II

2014-05-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00562-1

Beckman coulter has determined that some ultrasonic transducer kits were potentially assembled with incorrect mounting screws. one of these transducers may have been installed on the system during a recent instrument repair. over time the screws can become loose if a combination of correct and incorrect screws are used and possibly cause incorrect probe wash, splashing in the reaction vessels (rv), incorrect particle suspension in the reagent pack, or incorrect rv mix due to alignment of the probe to wash tower/rv leading to assay imprecision. this may cause erraneous but believable results and/or delay of results due to transducer alignment error.

Users are advised to review historical QC data and System Check results since the transducer was installed for any indication of a potential problem and determine whether a review of patient test results is warranted. A service representative will be contacting users to schedule a service visit to confirm that their transducer is properly installed.