Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Enforcement
- Recall Number
- Z-3180-2024
- Event ID
- 95156
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 25, 2024
- Initiation Date
- July 10, 2024
- Classification Date
- September 19, 2024
- Address
- 1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States
Description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
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.
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
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.
170 units