Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;
Summary
The FDA issued a Class II for Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM P by Beckman Coulter, Inc.. Reason: Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air le.
Details
Source
Device Recall
External ID
Z-3180-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Lot/Code Info: UDI/DI 15099590230623, Serial Numbers: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, 300156, 300157, 300158, 300160, 300161, 300162, 300163, 300164, 300166, 300167, 300168, 300169, 300170, 300171, 300172, 300174, 300176, 300178, 300179, 300180, 300181, 300182, 300183, 300188, 300189, 300190, 300192, 300193, 300194, 300195, 300196, 300197, 300198, 300199, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300219, 300220, 300221, 300222, 300223, 300224, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 300234, 300235, 300236, 300237, 300238, 300239, 300240, 300241, 300242, 300243, 300244, 300245, 300246, 300247, 300248, 300249, 300251, 300252, 300253, 300254, 300255, 300256, 300257, 300258, 300260, 300261, 300263, 300264, 300266, 300269, 300270, 300271, 300272, 300273, 300274, 300275, 300276, 300277, 300280, 300281, 300282, 300284, 300285, 300286, 300287, 300291, 300292, 300293, 300294, 300295, 300297, 300307, 300308, 300310, 300312, 300313, 300314, 300315, 300316, 300317, 300319, 300320, 300321, 300322, 300323, 300324, 300325, 300326, 300327, 300328, 300329, 300330, 300332, 300333
Quantity Affected: 170 units
Reason for Recall
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
Distribution
Worldwide distribution - US Nationwide and 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, Sweden, Switzerland, Taiwan, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-10
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 257 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-3180-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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