Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;

FDA device recall Z-3180-2024 · posted 2024-09-19 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JJE

Quantity affected

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,

Date initiated

2024-07-10

Date posted

2024-09-19

Location

Chaska, MN

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