Recall Z-2414-2024
Beckman Coulter, Inc. · initiated June 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Codes / lots: Serial numbers: 300117, 300116, 300137, 300138, 300139, 300129, 300141, 300143, 300142, 300151, 300152, 300128, 300156, 300153, 300154, 300135, 300164, 300180, 300155, 300167, 300166, 300158, 300171, 300179, 300169, 300182, 300176, 300183, 300198, 300192, 300133, 300188, 300161, 300134, 300190, 300209, 300212, 300211, 300149, 300148, 300150, 300130, 300172, 300197, 300160, 300189, 300170, 300181, 300195, 300194, 300224, 300222, 300168, 300210, 300233, 300207, 300205, 300221, 300203, 300240, 300199, 300200, 300136, 300196, 300178, 300220, 300208, 300126, 300213, 300206, 300219, 300214, 300217, 300215, 300229, 300255, 300257, 300202, 300254, 300223, 300258, 300259, 300218, 300201, 300234, 300237, 300249, 300260, 300238, 300243, 300261, 300231, 300191, 300131, 300236, 300264, 300263, 300193, 300239, 300230, 300235, 300245, 300216, 300247, 300242, 300226, 300270, 300271, 300269, 300174, 300251, 300241, 300232, 300204, 300227, 300228, 300256, 300266, 300281, 300282, 300253, 300244, 300272, 300246, 300145, 300123, 300147, 300297, 300157, 300275, 300284, 300286, 300248, 300273, 300252, 300144, 300146, 300165, 300177, 300173, 300250, 300268, and 300140; UDI-DI 15099590732103.
Reason for recall
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
FDA-determined cause: Nonconforming Material/Component
Action taken
Letters dated 5/29/2024 were issued via email and postal mail on 6/4/2024. The letter described the issue, the impact, and the action which was that the consignee's Beckman Coulter service representative will contact the consignee to replace parts affected by the issue. The firm will replace all affected USB 2.0 cables. The information in the letter is to be shared with the consignees laboratory staff and if the device has been forwarded to another laboratory, the consignee is requested to send them a copy of the letter. The consignee is requested to respond to the letter within 10 days either via email or by manually completing the enclosed Response Form.
Details
- Recall number
- Z-2414-2024
- Initiated
- June 4, 2024
- Posted by FDA
- July 23, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 143 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN