Z-1040-2017Class III

AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500...

Name: Z-1040-2017 AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500...
Creator: Beckman Coulter Inc.
Published: 2016-12-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-12-21 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550... on 2016-12-21. FDA classified it as Class III and gives the reason as "Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1040-2017
Classification: Class III
Status: Terminated
Initiated: 2016-12-21
Posted: 2017-01-18
Terminated: 2017-05-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Root cause tag: design
FDA root cause: Under Investigation by firm
Action: The firm, Beckman Coulter, initiated a cite visit to correct the 4 systems installed. The firm will perform the correction by Field Service and tracked via Service Modification. If you have any questions, contact the VP, Global Quality Systems & Compliance at 714-961-4933 or email: [email protected].
Quantity in commerce: 4 units
Distribution: US Distribution to MD only.
Product codes and lots: ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1040-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1040-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)