Beckman Coulter DxI 9000 Access Immunoassay Analyzer recall: Software Issue
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Why was Beckman Coulter DxI 9000 Access Immunoassay Analyzer recalled?
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
What should I do if I have this product?
Review the official FDA enforcement record for current 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, 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.
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 61 units
- 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.
- Recall date
- February 12, 2025
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)