Z-1169-2018Class II

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number...

Name: Z-1169-2018 AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number...
Creator: Beckman Coulter Inc.
Published: 2018-01-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-01-19 / Completed / root cause: design

FDA source

Beckman Coulter Inc. began a recall of AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255 on 2018-01-19. FDA classified it as Class II and gives the reason as "Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-1169-2018
Classification: Class II
Status: Completed
Initiated: 2018-01-19
Posted: 2018-03-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter plans to replace the belt via Service Modification during the next planned service maintenance visit. At that time, the customer will be informed of the belt replacement by the service engineer.
Quantity in commerce: 98 units in the US
Distribution: Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Product codes and lots: All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1169-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1169-2018	Class II	Completed	Voluntary: Firm initiated	2018-03-28	2018-03-22

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)