Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Summary
The FDA issued a Class II for Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in- by Beckman Coulter, Inc.. Reason: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results..
Details
Source
Device Recall
External ID
Z-1115-2025
Action Date
2025-02-12
Status
Completed
Category
device
Product Description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Lot/Code Info: UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.
Quantity Affected: 61 units
Reason for Recall
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-03
Company
Chaska, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1115-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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