FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
- Recall number
- Z-1529-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
- Status
- Open, Classified
- Initiated
- 2024-07-12
- Posted
- 2025-04-04
- Terminated
- not on file
- Reason
- Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
- Root cause
- Device Design
- Action
- The firm sent notice of "Urgent Medical Device Recall" to affected consignees (all OUS), dated July 3, 2024. Customers were informed of the potential for barcode read failure error, delay of reporting patient test results, and possibility for a small amount of smoke to be emitted. Consignees were advised that no action was necessary if their laboratory has not observed any RSM Barcode Read Failure error messages. If you do observe any such error messages, or notice smoking or burning smell coming from the Dxl 9000 analyzer, please contact your Beckman Coulter service representative. Beckman Coulter will no longer ship these analyzers with the affected ground screw. Your Beckman Coulter service representative will contact you to schedule a part replacement that resolves the issue.
- Quantity
- 30 OUS
- Distribution
- OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.
- Lot, serial or model codes
- UDI-DI 15099590732103 Serial/Lot Numbers: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, and 300156
- 510(k) numbers
- ["K221225"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
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