FDA Medical Device Recalls (openFDA)
Beckman Coulter Biomedical GmbH: Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Recall number
- Z-2145-2023
- Recalling firm
- Beckman Coulter Biomedical GmbH
- Product
- Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Status
- Open, Classified
- Initiated
- 2023-06-02
- Posted
- 2023-07-14
- Terminated
- not on file
- Reason
- 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
- 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
- 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,
- Lot, serial or model codes
- UDI-DI: (01)15099590707118, All DxA serial numbers
- 510(k) numbers
- ["K190298"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3006677029
- Firm city
- Munchen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28