Beckman Coulter DxA Automation System, DxA 5000 Fit, REF:… recallZ-2145-2023 · Beckman Coulter Biomedical GmbH · initiated Jun 2, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Beckman Coulter Biomedical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

FDA root cause category: Software design

What the company is doing

On 06/12/2023, Beckman Coulter issued an Urgent Medical Device Recall Notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. Inspect tubes routed to error regions and confirm that the tube type was appropriate per the assay IFU for the test performed. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email./" Manually, complete and return the enclosed Response Form. 4. If you have any questions regarding this notice, please contact our Customer Support Center or your local Beckman Coulter Representative: " From our website: http://www.beckmancoulter.com/" By phone: call 1-800-526-3821 in the United States. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recall details

Recall number: Z-2145-2023
Status: Open, Classified
Initiated by the company: Jun 2, 2023
Posted by the FDA: Jul 14, 2023
Recalling firm: Beckman Coulter Biomedical GmbH
Quantity: 15
Product code: JJE
FDA submissions: K190298
Distribution: US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,

Product description

Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Code information (models, lots, serial numbers)

UDI-DI: (01)15099590707118, All DxA serial numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

DxA 5000
Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92484).

Z-2144-2023 · Open, Classified
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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