Beckman Coulter DxI 9000 Access Immunoassay Analyzer… recallZ-2544-2024 · Beckman Coulter, Inc. · initiated May 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2544-2024
- Status
- Open, Classified
- Initiated by the company
- May 22, 2024
- Posted by the FDA
- Aug 9, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 183 devices
- Product code
- JJE
- 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, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Code information (models, lots, serial numbers)
Software versions 1.17 and below, UDI-DI 15099590732103.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DxI 9000 Access Immunoassay Analyzer C11137Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use17 recalls1 death3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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