Beckman Coulter—Access 2 Immunoassay System Software 3.6.0 Package: Installation May Fail, Potentially Rendering the Analyzer Inoperable

ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a February 12, 2020, Important Product Notice letter submitted by an ECRI Institute member hospital, Beckman Coulter states that installation failures have been observed when upgrading to the above software from versions 3.4.2, 3.4.3, and 3.5.0, potentially rendering the analyzer inoperable. If this occurs, the user may receive an error message. Beckman Coulter also states that this problem has no effect on patient results or routine maintenance procedures, and that there is no effect on the operation of the 3.6.0 software once installed. The manufacturer has not confirmed the...