Z-3180-2024Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2...

Name: Z-3180-2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2...
Creator: Beckman Coulter, Inc.
Published: 2024-07-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument on 2024-07-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3180-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-10
Posted: 2024-09-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/10/2024 via US mail and email. The notice explained the problem, impact, and requested the following actions be taken: If your laboratory observes either of these system eventscontact the Beckman Coulter Customer Technical Support Center at 1-800-854-3633 (US and Canada) or your local Beckman Coulter representative (outside US and Canada: a). Chassis.Pneumatics MachineControlStatus(Chassis maintain system air pressure failed. 1.The compressor has failed. 2.A large leak exists in the system) b). Pneumatics Air pressure under limit: ### PSI, Chassis.Pneumatics. WS04CompressedAir.32-35psi.PressureSensor. Beckman Coulter will schedule a time to replace the RSM pneumatic tubing.
Quantity in commerce: 170 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3180-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3180-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code JJE

K221225Class IIAccess TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. / cleared 2022-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)