Z-0492-2020Class II

AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed...

Name: Z-0492-2020 AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed...
Creator: Beckman Coulter Inc.
Published: 2018-11-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-11-09 / Open, Classified

FDA source

Beckman Coulter Inc. began a recall of AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083... on 2018-11-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0492-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-09
Posted: 2019-11-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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) .
FDA 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 in commerce: 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
Product codes and lots: All units containing software Version(s) 4.1.1 and up

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0492-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0492-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-27	2019-11-18

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)