FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
- Recall number
- Z-0492-2020
- Recalling firm
- Beckman Coulter Inc.
- Product
- AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
- Status
- Open, Classified
- Initiated
- 2018-11-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .
- Root cause
- Other
- Action
- A "Urgent Medical device Recall" letter was sent to affected consignees on November 9, 2018 via USPS. The letter informed consignees of the following: 1. If you are using the MTP kit option of the AutoMate 2500 Family systems, please ensure that your system meets the required software prerequisites stated in the Issue section. " If the requirements are met, you can safely continue using your system. " If the requirements are not met; Permanently discontinue using the MTP kit option or Contact your Beckman Coulter representative to upgrade your system to meet the required software prerequisites. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 3. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. 5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. 6. If you have any questions regarding this notice, please contact Beckman Coulter via: http://www.beckmancoulter.com; by phone (800) 526-3821, or your local Beckman Coulter representative.
- Quantity
- 83 automate systems
- Distribution
- US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom
- Lot, serial or model codes
- All units containing software Version(s) 4.1.1 and up
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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