Beckman Coulter, Inc. Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
Software versions 1.17 and below, UDI-DI 15099590732103.
Products Sold
Software versions 1.17 and below, UDI-DI 15099590732103.
Beckman Coulter, Inc. is recalling Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. due to The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 patient treatment.
Recommended Action
Per FDA guidance
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 the Dxl 9000 Access Immunoassay Analyzer from the sample handler input area. The letter informs the consignee that Beckman Coulter has identified the root cause of the issue and will implement the correction with a future software release. Beckman Coulter will contact the consignee to schedule the software upgrade when it is available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026