Z-0059-2013Class II

Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i...

Name: Z-0059-2013 Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i...
Creator: Beckman Coulter Inc.
Published: 2012-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-07-06 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number... on 2012-07-06. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0059-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-06
Posted: 2012-10-12
Terminated: 2012-11-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause a hardware motion error (ID0x08000501).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recall notification was initiated on July 6, 2012 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form to all customers who purchased the UniCel DxC 880i, UniCel DxC 860i, UniCel 680i, UniCel DxC 660i Clinical System Integrated Workstations UCTA Sample Syringe Pump Drive Assembly. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Beckman Coulter will schedule a Service Call to replace the affected sample syringe pump drive assemblies. Customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any questions regarding the PCA, were instructed to call Customer Support at (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact Beckman Coulter Representative.
Quantity in commerce: 18 units
Distribution: Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.
Product codes and lots: Serial Numbers: 547-574 (UCTA)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0059-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-12

Product code JJE

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)