DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware… recallZ-0107-2024 · Beckman Coulter, Inc. · initiated Sep 12, 2023
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 firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
FDA root cause category: Software design
What the company is doing
Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware). Current customers should perform one of the following: Option 1: Disconnect the DxI 9000 Access Immunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console. Option 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer. Beckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.
Recall details
- Recall number
- Z-0107-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2023
- Posted by the FDA
- Oct 12, 2023
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 36 units
- Product code
- JJE
- FDA submissions
- K221225
- Distribution
- Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Product description
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Code information (models, lots, serial numbers)
UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior
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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