Z-1972-2011

UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405...

Name: Z-1972-2011 UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405...
Creator: Beckman Coulter Inc.
Published: 2010-11-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-11-16 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part... on 2010-11-16. The reason FDA records is "The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the...". 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-1972-2011
Status: Terminated
Initiated: 2010-11-16
Posted: 2011-04-13
Terminated: 2012-06-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #: A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: The recall communication was initiated with Beckman Coulter forwarding a Product Corrective Action Letter (PCA) dated November 16, 2010 to the affected customers. The recall notice explained the reason for recall and asked that customers take the following actions: (1) Customers with a service contract will have hose clamp covers installed by their Field Service Engineer during the next scheduled Preventive Maintenance (PM). A kit can be ordered through their Customer Service Representative if consignees prefer not to wait for the next Preventive Maintenance visit and (2) Customers without a service contract can obtain a kit by contacting their local Customer Service Representative. Customers were also informed that Kit (PN A68986) containing hose clamp covers and installation instructions is available at no charge from their Customer Service Representatives. One kit is required for each DxC system. The following telephone numbers were given for customers to obtain the kits: (800) 526-3821 (United States) and (800) 463-7828 (Canada). Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If any of the affected product was forwarded on to another laboratory they were asked to provide a copy of this letter to them. Questions are to be directed to Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.
Quantity in commerce: 1,535 units
Distribution: Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom.
Product codes and lots: UniCel DxC Clinical Systems with Serial Number less than 3412 (with serial numbers less than 3412, labeled behind the lower right side instrument door) UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102 Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP.

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)