Recall Z-2544-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
| Date | Aug 9, 2024 (initiated May 22, 2024) |
| Status | Open, Classified |
| Reason | The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and pat |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 5/16/2024 on 5/22/2024 via mail and email. The letter provided the issue, impact, and actions to take. The actions included: (1) If the issue occurs, initialize the system as prompted by the analyzer; (2) Contact the Beckman Coulter representative and schedule a service visit if the laboratory has experienced sample PnP or aliquot pipettor error that is not resolved by initializing the system; (3) If samples received an NRT flag, request the test again and reload the sample; (4) Identify any sample tubes that were not processed and reload them on th |
| Quantity | 183 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, and TX. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Port |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.