Beckman Coulter DxI 9000 Access Immunoassay Analyzer recall: Software Issue
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Why was Beckman Coulter DxI 9000 Access Immunoassay Analyzer 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.
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?
Software versions 1.17 and below, UDI-DI 15099590732103.
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 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 Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
- Recall date
- August 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)