Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

FDA device recall Z-2544-2024 · posted 2024-08-09 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

JJE

Quantity affected

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 Repub

Date initiated

2024-05-22

Date posted

2024-08-09

Location

Chaska, MN