Z-0056-2013Class II

AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is...

Name: Z-0056-2013 AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is...
Creator: Beckman Coulter Inc.
Published: 2012-04-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-04-11 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample... on 2012-04-11. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0056-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-11
Posted: 2012-10-12
Terminated: 2013-02-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 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 processes. 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 the 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: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Beckman Coulter initiated an Urgent Product Correction letter dated April 11, 2012, with attached PCA Response Form to all customers who purchased the affected product. . The letter identified the product, the problem, and the action taken by the customer. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local Beckman Coulter representative. Customers with questions should call 714-993-5321. For questions regarding this recall call 714-961-4941.
Quantity in commerce: 468 units total (51 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0056-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0056-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-12

Product code JQW

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)