Recall Z-2544-2024— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2024-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.. Reason: 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..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-22
- Firm location
- Chaska, MN, United States
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.