Z-2145-2023Class II

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

Name: Z-2145-2023 Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Creator: Beckman Coulter Biomedical GmbH
Published: 2023-06-02
License: https://open.fda.gov/license/

Beckman Coulter Biomedical GmbH / initiated 2023-06-02 / Open, Classified / root cause: software

FDA source

Beckman Coulter Biomedical GmbH began a recall of Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly on 2023-06-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2145-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-02
Posted: 2023-07-14
Recalling firm: Beckman Coulter Biomedical GmbH
Product: Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 15
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 codes and lots: UDI-DI: (01)15099590707118, All DxA serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2145-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2144-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2145-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14

Product code JJE

K190298Class IIDxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH / cleared 2019-10-04

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)