Question 1

Is Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use.  It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137. recalled?

Accepted Answer

Beckman Coulter, Inc. is recalling 9 units of the DxI 9000 Access Immunoassay Analyzer because pneumatic tubing within the device can disconnect during operation. This defect can lead to incorrect cleaning of testing materials, resulting in artificially high or low test signals and potentially false patient results. The defect was first identified during internal inspections in February 2024. Consumers should be aware that this issue can lead to significant delays in reporting critical test results, such as troponin levels used in emergency medical decisions. Because this is a professional medical device, you should contact the manufacturer or your healthcare provider for instructions on how to proceed.

Question 2

What should I do?

Accepted Answer

Identify if your facility is using a Beckman Coulter DxI 9000 Access Immunoassay Analyzer with Catalog Number C11137. Check the device serial number located on the instrument. The affected serial numbers are: 300273, 300275, 300276, 300277, 300281, 300282, 300284, 300286, and 300297. Verify the device UDI/DI 15099590732103 to confirm it is part of this recall. If your device is affected, monitor for System Event log messages indicating 'PnP errors', 'SYS' flags on cancelled tests, or a 'Red-system' status. Contact Beckman Coulter, Inc. directly at their Chaska, Minnesota facility or through your local representative to arrange for a technician to inspect and repair the pneumatic tubing assembly. Consult with your healthcare provider or laboratory director regarding any suspicious or cancelled test results that may have occurred during the period the device was in use. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or the manufacturer for further instructions and potential refund

Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzer Recalled for Potential False Test Results

Summary

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