Beckman Coulter DxI 9000 Access Immunoassay Analyzer recall
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Why was Beckman Coulter DxI 9000 Access Immunoassay Analyzer recalled?
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 370 units
- Distribution
- Worldwide distribution.
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)